Published Studies

The following publications from 2021-2023 highlight clinical studies completed at the Duke Neonatal Perinatal Research Unit.

• Maternal Factors Impacting Neonates
• Birth Trauma / Hypoxic Ischemic Encephalopathy 
• Neurology
• Ophthalmology
• Pulmonary
• Cardiovascular
• Gastrointestinal
• Infection
• Nutrition and Growth
• Management of Complex Issues
• Neonatal Opioid Withdrawal Syndrome (NOWS)
• Surgical Issues
• Long-term Outcomes
• Palliative Care
• Technology in the NICU
• Healthcare System Management/Research
• Medical Education
• Global Health
• Academic Setting

Maternal Factors Impacting Neonates

• Relationship between preterm mortality/morbidity in relation to maternal BMI

Chawla S, Laptook AR, Smith EA, Tan S, Natarajan G, Wyckoff MH, Ambalavanan N, Bell EF, Van Meurs KP, Stenson DK, Werner E, Greenberg RG, Das A, Shankaran S. In-hospital mortality and morbidity among extremely preterm infants in relation to maternal body mass index. Journal of Perinatology 2021 May;41(5):1014-1024. PMC8021608.

• Outcomes of preterm infants of insulin-dependent diabetic mothers

Gray KD, Saha S, Battarbee AN, Cotten CM, Boghossian NS, Walsh MC, and Greenberg RG; Eunice Kennedy Shriver National Institute of Child Health Human Development Neonatal Research Network. Outcomes of Moderately Preterm Infants of Insulin-Dependent Diabetic Mothers. Am J Perinatol. 2022 May 17. Epub ahead of print. PMID: 35299277 DOI: 10.1055/a-1801-3050

• Current knowledge related to infection-related stillbirth

Aleem S, Bhutta ZA. Infection-related stillbirth: an update on current knowledge and strategies for prevention. Expert Rev Anti Infect Ther. 2021 Sep;19(9):1117-1124. doi: 10.1080/14787210.2021.1882849. Epub 2021 Feb 10. PMID: 33517816.

Birth Trauma / Hypoxic Ischemic Encephalopathy

• Limitations of MRI imaging as a predictor of death or disability in HIE

Laptook AR, Shankaran S, Barnes P, Rollins N, Do BT, Parikh NA, Hamrick S, Hintz SR, Tyson JE, Bell EF, Ambalavanan N, Goldberg RN, Pappas A, Huitema C, Pedroza C, Chaudhary AS, Hensman AM, Das A, Wyckoff M, Khan A, Walsh MC, Watterberg KL, Faix R, Truog W, Guillet R, Sokol GM, Poindexter BB, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic- Ischemic Encephalopathy in the Late Hypothermia Trial. J Pediatr. 2021 Mar;230:106-111.e6. doi: 10.1016/j.jpeds.2020.11.015. Epub 2020 Nov 13. PMID: 33189747; PMCID: PMC7914162.

• Association between increased seizures with HIE during rewarming and 2-year outcomes

Chalak LF, Pappas A, Tan S, Das A, Sánchez PJ, Laptook AR, Van Meurs KP, Shankaran S, Bell EF, Davis AS, Heyne RJ, Pedroza C, Poindexter BB, Schibler K, Tyson JE, Ball MB, Bara R, Grisby C, Sokol GM, D'Angio CT, Hamrick SEG, Dysart KC, Cotten CM, Truog WE, Watterberg KL, Timan CJ, Garg M, Carlo WA, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association Between Increased Seizures During Rewarming After Hypothermia for Neonatal Hypoxic Ischemic Encephalopathy and Abnormal Neurodevelopmental Outcomes at 2-Year Follow-up: A Nested Multisite Cohort Study. JAMA Neurol. 2021 Dec 1;78(12):1484-1493. doi: 10.1001/jamaneurol.2021.3723. PMID: 34882200.

• Early determination of prognosis in moderate or severe HIE

Ambalavanan N, Shankaran S, Laptook AR, Carper BA, Das A, Carlo WA, Cotten CM, Duncan AF, Higgins RD; EUNICE KENNEDY SHRIVER NICHD NEONATAL RESEARCH NETWORK. Early Determination of Prognosis in Neonatal Moderate or Severe Hypoxic-Ischemic Encephalopathy. Pediatrics. 2021 Jun;147(6):e2020048678. doi: 10.1542/peds.2020-048678. Epub 2021 May 13. PMID: 33986149; PMCID: PMC8168606.

• Blanket temperature during hypothermia and outcomes in HIE

Flibotte J, Laptook AR, Shankaran S, McDonald SA, Baserga MC, Bell EF, Cotten CM, Das A, DeMauro SB, DuPont TL, Eichenwald EC, Heyne R, Jensen EA, Van Meurs KP, Dysart K; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Blanket temperature during therapeutic hypothermia and outcomes in hypoxic ischemic encephalopathy. J Perinatol. 2022 Mar;42(3):348-353. doi: 10.1038/s41372-021-01302-4. Epub 2022 Jan 8. PMID: 34999716; PMCID: PMC9121861.

• Developing future clinical trials for treatment of HIE

Benninger KL, Inder TE, Goodman AM, Cotten CM, Nordli DR, Shah TA, Slaughter JC, Maitre NL. Perspectives from the Society for Pediatric Research. Neonatal encephalopathy clinical trials: developing the future. Pediatr Res. 2021 Jan;89(1):74-84. doi: 10.1038/s41390-020-0859-9. Epub 2020 Mar 27. PMID: 32221474; PMCID: PMC7529683.

Neurology

• Adrenal hemorrhage complicating neonatal encephalopathy

Curtis SF, Moreira D, Benjamin RW, Weimer KED. Bilateral adrenal hemorrhage complicating neonatal encephalopathy.  Accepted to J Pediatr Endocrinol, May 2022 Vol 7 Issue 1.

• Targeting the latent, secondary and tertiary phases of evolving brain injury

Chakkarapani AA, Aly H, Benders M, Cotten CM, El-Dib M, Gressens P, Hagberg H, Sabir H, Wintermark P, Robertson NJ; Newborn Brain Society Guidelines and Publications Committee. Therapies for neonatal encephalopathy: Targeting the latent, secondary and tertiary phases of evolving brain injury. Semin Fetal Neonatal Med. 2021 Oct;26(5):101256. doi: 10.1016/j.siny.2021.101256. Epub 2021 Jun 12. PMID: 34154945.

• Early brain and abdominal oxygenation of ELBW infants

Chock VY, Smith E, Tan S, Ball MB, Das A, Hintz SR, Kirpalani H, Bell EF, Chalak LF, Carlo WA, Cotten CM, Widness JA, Kennedy KA, Ohls RK, Seabrook RB, Patel RM, Laptook AR, Mancini T, Sokol GM, Walsh MC, Yoder BA, Poindexter BB, Chawla S, D'Angio CT, Higgins RD, Van Meurs KP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early brain and abdominal oxygenation in extremely low birth weight infants. Pediatr Res. 2022 Oct;92(4):1034-1041. doi: 10.1038/s41390-022-02082-z. Epub 2022 May 5. PMID: 35513716; PMCID: PMC9588487.

Ophthalmology

• Biphasic change in retinal nerve fiber layer thickness in preterm infants

Shen LL, Mangalesh S, McGeehan B, Seely KR, Tai V, Sarin N, Finkle J, Winter KP, Tran-Viet D, Freedman SF, El-Dairi MA, Ying GS, Toth CA. Biphasic change in retinal nerve fibre layer thickness from 30 to 60 weeks postmenstrual age in preterm infants. Br J Ophthalmol. 2022 Sep 16:bjophthalmol-2022-321621. doi: 10.1136/bjo-2022-321621. Epub ahead of print. PMID: 36113954.

• Preterm infant stress during examination for ROP using different devices

Mangalesh S, Sarin N, McGeehan B, Prakalapakorn SG, Tran-Viet D, Cotten CM, Freedman SF, Maguire MG, Toth CA; BabySTEPS Group. Preterm Infant Stress During Handheld Optical Coherence Tomography vs Binocular Indirect Ophthalmoscopy Examination for Retinopathy of Prematurity. JAMA Ophthalmol. 2021 May 1;139(5):567-574. doi: 10.1001/jamaophthalmol.2021.0377. PMID: 33792625; PMCID: PMC8017483.

• Macular OCT characteristics at 36 weeks' PMA in infants examined for ROP

Mangalesh S, McGeehan B, Tai V, Chen X, Tran-Viet D, Vajzovic L, Viehland C, Izatt JA, Cotten CM, Freedman SF, Maguire MG, Toth CA; Study of Eye Imaging in Preterm Infants Group. Macular OCT Characteristics at 36 Weeks' Postmenstrual Age in Infants Examined for Retinopathy of Prematurity. Ophthalmol Retina. 2021 Jun;5(6):580-592. doi: 10.1016/j.oret.2020.09.004. Epub 2020 Sep 11. PMID: 32927150; PMCID: PMC7947027.

• Retinal changes in ROP from 3-dimensional OCT data

Mangalesh S, Seely KR, Tran-Viet D, Tai V, Chen X, Prakalapakorn SG, Freedman SF, Toth CA; BabySTEPS Group. Integrated Visualization Highlighting Retinal Changes in Retinopathy of Prematurity From 3-Dimensional Optical Coherence Tomography Data. JAMA Ophthalmol. 2022 Jul 1;140(7):725-729. doi: 10.1001/jamaophthalmol.2022.1344. PMID: 35616956; PMCID: PMC9136675.

Pulmonary

• Use of hydrocortisone in management of PPHN of the newborn

Aleem S, Robbins C, Murphy B, Elliott S, Akinyemi C, Paredes N, Tolia VN, Zimmerman KO, Goldberg RN, Benjamin DK, and Greenberg RG. The Use of Supplemental Hydrocortisone in the Management of Persistent Pulmonary Hypertension of the Newborn. J Perinatology 2021 Apr;41(4):794-800. PMC8052278

• Should vitamin A injections to prevent BPD or death be reserved for high-risk infants?

Rysavy MA, Li L, Tyson JE, Jensen EA, Das A, Ambalavanan N, Laughon MM, Greenberg RG, Patel RM, Pedroza C, Bell EF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Should Vitamin A Injections to Prevent Bronchopulmonary Dysplasia or Death Be Reserved for High-Risk Infants?: Reanalysis of the NICHD Neonatal Research Network Randomized Trial. J Pediatr 2021 May 15;S0022-3476(21)00445-5. PMC8403138

• Respiratory setback associated with extubation failure in ELBW infants

Gupta D, Greenberg RG, Natarajan G, Jani S, Sharma A, Cotten M, Thomas R, Chawla S. Respiratory setback associated with extubation failure in extremely preterm infants. Pediatr Pulmonol 2021 Jul;56(7):2081-2086. PMID: 33819392 DOI: 10.1002/ppul.25387

• Comparative efficacy and safety of late surfactant preparations

Gupta D, Greenberg RG, Sharma A, Natarajan G, Cotten M, Thomas R, Chawla S. A Predictive Model for Extubation Readiness in Extremely Preterm Infants. J Perinatol. 2019 Dec;39(12):1663-1669.

• Prevention and management of BPD

Hennelly M, Greenberg RG, Aleem S. An update on the prevention and management of bronchopulmonary dysplasia. Pediatric Health Med Ther. 2021 Aug 11;12:405-419. PMC8290378

• Evaluation and validation of a prediction model for extubation success in VLBW infants

Dryer RA, Salem A, Saroha V, Greenberg RG, Rysavy M, Chawla S, Patel RM. Evaluation and Validation of a Prediction Model for Extubation Success in Very Preterm Infants. Journal of Perinatology. PMID: 36153409 DOI: 10.1038/s41372-022-01517-z

• Hydrocortisone to improve survival without BPD

Watterberg KL, Walsh MC, Li L, Chawla S, D'Angio CT, Goldberg RN, Hintz SR, Laughon MM, Yoder BA, Kennedy KA, McDavid GE, Backstrom-Lacy C, Das A, Crawford MM, Keszler M, Sokol GM, Poindexter BB, Ambalavanan N, Hibbs AM, Truog WE, Schmidt B, Wyckoff MH, Khan AM, Garg M, Chess PR, Reynolds AM, Moallem M, Bell EF, Meyer LR, Patel RM, Van Meurs KP, Cotten CM, McGowan EC, Hines AC, Merhar S, Peralta-Carcelen M, Wilson-Costello DE, Kilbride HW, DeMauro SB, Heyne RJ, Mosquera RA, Natarajan G, Purdy IB, Lowe JR, Maitre NL, Harmon HM, Hogden LA, Adams-Chapman I, Winter S, Malcolm WF, Higgins RD; Eunice Kennedy Shriver NICHD Neonatal Research Network. Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia. N Engl J Med. 2022 Mar 24;386(12):1121-1131. doi: 10.1056/NEJMoa2114897. PMID: 35320643; PMCID: PMC9107291.

• Contribution of NICHD NRN to management of BPD

Jensen EA, Laughon MM, DeMauro SB, Cotten CM, Do B, Carlo WA, Watterberg KL. Contributions of the NICHD neonatal research network to the diagnosis, prevention, and treatment of bronchopulmonary dysplasia. Semin Perinatol. 2022 Nov;46(7):151638. doi: 10.1016/j.semperi.2022.151638. Epub 2022 Jun 10. PMID: 36085059.

• Accurate prediction of BPD

 Aleem S, Greenberg RG. Accurate Prediction of Bronchopulmonary Dysplasia: Are We There Yet? J  Pediatr. 2023 Mar 16:113389. doi: 10.1016/j.jpeds.2023.03.004. Epub ahead of print. PMID: 36933768.

Cardiovascular

• Covariation of changing PDA management and preterm outcomes

Hagadorn JI, Shaffer ML, Tolia VN, and Greenberg RG. Covariation of changing patent ductus arteriosus management and preterm infant outcomes in Pediatrix neonatal intensive care units. J Perinatol. 2021 Oct;41(10):2526-2531. PMID: 34354226 DOI: 10.1038/s41372-021-01170-y

• Survival, morbidities, and outcomes among LBW infants with CHD

Puia-Dumitrescu M, Sullivan LN, Tanaka D, Fisher K, Pittman R, Kumar KR, Malcolm WF, Gustafson KE, Lodge AJ, Goldberg RN, Hornik CP. Survival, Morbidities, and Developmental Outcomes among Low Birth Weight Infants with Congenital Heart Defects. Am J Perinatol. 2021 Nov;38(13):1366-1372. doi:10.1055/s-0040-1712964. Epub 2020 Jun 2. PMID: 32485756.

Infection

• EOS in term infants

Polcwiartek LB, Smith PB, Benjamin D, Zimmerman K, Love A, Tiu L, Murray S, Kang P, Ebbesen F, Hagstrom S, Clark RH, and Greenberg RG. Early-Onset Sepsis in Term Infants Admitted to Neonatal Intensive Care Units (2011–2016). Journal of Perinatology. 2021 Jan;41(1):157-163. PMC7568457

• Management and prevention of neonatal invasive candidiasis

Kilpatrick R, Scarrow E, Hornik C, and Greenberg RG. Neonatal invasive candidiasis: updates on clinical management and prevention. Lancet Child Adolesc Health. 2022 Jan;6(1):60-70. doi: 10.1016/S2352-4642(21)00272-8. Epub 2021 Oct 19. PMID: 34672994.

• Ampicillin dosing in preterm infants for EOS

Le J, Greenberg RG, Yoo YoungJun, Clark RH, Benjamin DK, Zimmerman KO, Cohen-Wolkowiez M, Wade KC, and the Administrative Core Committee of the Best Pharmaceuticals for Children Act – Pediatric Trials Network*. Ampicillin Dosing in Premature Infants for Early-onset Sepsis: Exposure-driven Efficacy, Safety, and Stewardship. Journal of Perinatology 2022 Feb 24. PMID: 35210541 PMCID: PMC9262754 DOI: 10.1038/s41372-022-01344-2

• Pharmacokinetics of moxifloxacin

Greenberg RG, Landersdorfer CB, Rivera-Chaparro N, Harward M, Conrad T, Nakamura A, Kirkpatrick CM, Gu K, Ghazaryhan V, Osborn B, Walter EB. Population Pharmacokinetics of Moxifloxacin in Children. Paediatric Drugs 2022 Mar;24(2):163-173. doi: 10.1007/s40272-022-00493-3. Epub 2022 Mar 14. PMID:35284983; PMCID: PMC9768852

• Trends in global mortality of sepsis among infants <90 days of age

Gan MY, Lee WL, Yap BJ, Seethor STT, Greenberg RG, Pek JH, Tan B, Hornik CPV, Lee JH, Chong SL. Contemporary Trends in Global Mortality of Sepsis Among Young Infants Less Than 90 Days: A Systematic Review and Meta-Analysis. Front Pediatr. 2022 Jun 3;10:890767. PMC9204066.

• Pharmacodynamics of meropenem and tobramycin in neonatal meningoencephalitis

Farrington N, McEntee L, Johnson A, Unsworth J, Darlow C, Jimenez-Valverde A, Hornik C, Greenberg RG, Schwartz J, Das S, Hope W. Pharmacodynamics of Meropenem and Tobramycin for Neonatal Meningoencephalitis: Novel Approaches to Facilitate the Development of New Agents to Address the Challenge of Antimicrobial Resistance. Antimicrobial Agents and Chemotherapy. Accepted for publication. PMID: 35315689 PMCID: PMC9017387 DOI: 10.1128/aac.02181-21

• Invasive fungal infections in neonates

Weimer KED, Smith PB, Puia-Dumitrescu M, Aleem S.  Invasive fungal infections in neonates: a review.  Pediatr res. 2022 Jan;91(2):404-412. DOI: 10.1038/s41390-021-01842-7.Epub 2021 Dec 9. PMID: 348804444.

• Short-term outcomes of 35 weeks gestation infants receiving care in Level II NICU

Weimer KED, Bidegain M, Shaikh SK, Couchet P, Tanaka DT, Athavale K. Comparison of short-term outcomes of 35-weeks’ gestation infants cared for in a level II NICU vs mother-baby, a retrospective study.  J Neonatal Perinatal Med. 2022 May 30. doi: 10.3233/NPM-221015. Epub ahead of print. PMID: 35661024.

• Fluconazole treatment and prophylaxis for invasive candidiasis in neonates

Hornik CD, Bondi DS, Greene NM, Cober MP, John B. Review of Fluconazole Treatment and Prophylaxis for Invasive Candidiasis in Neonates. J Pediatr Pharmacol Ther. 2021;26(2):115-122. doi: 10.5863/1551-6776-26.2.115. Epub 2021 Feb 15. PMID: 33603574; PMCID: PMC7887891.

[The section below is currently under construction.]

Nutrition and Growth

• Early pumping frequency and CTV for MOM in hospitalized infants

Mago-Shah DD, Athavale K, Fisher K, Heyward E, Tanaka D, Cotten CM. Early pumping frequency and coming to volume for mother's own milk feeding in hospitalized infants. J Perinatol. 2023 Apr 10. doi: 10.1038/s41372-023-01662-z. Epub ahead of print. PMID: 37037987.

Management of Complex Issues

• Association between nephrotoxic drug combinations and AKI in the NICU

Salerno SN, Liao Y, Jackson W, Greenberg RG, McKinzie CJ, McCallister A, Benjamin DK, Laughon MM, Clark RH, and Gonzalez D. Association between Nephrotoxic Drug Combinations and Acute Kidney Injury in the Neonatal Intensive Care Unit. Journal of Pediatrics 2021 Jan; 228:213-219. PMC7752849.

• Thrombosis in infants in the NICU setting

Robinson V, Achey MA, Nag UP, Reed CR, Pahl KS, Greenberg RG, Clark RH, and Tracy ET. Thrombosis in Infants in the Neonatal Intensive Care Unit: Analysis of a Large National Database. Journal of Thrombosis and Haemostasis. 2021 Feb;19(2):400-407.

• Long-term outcomes after postnatal CMV infection in LBW infants

Stark A, Cantrell S, Greenberg RG, Permar SR, Weimer KED. Long-term Outcomes after Postnatal Cytomegalovirus Infection in Low Birthweight Preterm Infants: A Systematic Review. Pediatr Infect Dis J. 2021 Jun 1;40(6):571-581. PMID: 33902071 DOI: 10.1097/INF.0000000000003072

• Vasoactive medication in ELBW in first postnatal week

Miller L, Laughon MM, Clark RH, Zimmerman KO, Hornik CP, Aleem S, Smith PB, and Greenberg RG. Vasoactive medications in extremely low gestational age neonates during the first postnatal week. J Perinatology. 2021 Sep;41(9):2330-2336. PMID: 33758384 PMCID: PMC9204669       DOI: 10.1038/s41372-021-01031-8

• Physiologically based PK modeling of meropenem in preterm and term infants

Ganguly S, Edginton AN, Gerhart JG, Cohen-Wolkowiez M, Greenberg RG, Gonzalez D Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Physiologically Based Pharmacokinetic Modeling of Meropenem in Preterm and Term Infants. Clin Pharmacokinet. 2021 Dec;60(12):1591-1604. PMC861681.

• Risk factors among infants receiving dialysis in the NICU

Sanderson K, Warady B, Carey W, Tolia V, Boynton MH, Benjamin DK, Jackson W, Laughon M, Clark RH, and Greenberg RG. Mortality Risk Factors Among Infants Receiving Dialysis in the Neonatal Intensive Care Unit. J Pediatr. 2022 Mar;242:159-165. doi: 10.1016/j.jpeds.2021.11.025. Epub 2021 Nov 16. PMC8882152.

• PK of exebacase in an infant with disseminated Staph aureus infection

Moorthy GS, Greenberg RG, Hornik CD, Cassino C, Ghahramani P, Kumar KR, Fowler VG, Cohen-Wolkowiez M. Safety and Pharmacokinetics of Exebacase in an Infant with Disseminated Staphylococcus aureus Infection. Clin Infect Dis. 2021 Dec 11. Epub ahead of print. PMID: 34894129. PMCID: PMC9410717 DOI: 10.1093/cid/ciab1015.

• Association between PMA and furosemide dosage practices in preterm infants

Bamat N, Thompson EJ, Greenberg RG, Lorch SA, Zuppa AF, Eichenwald EC, Tolia VN, Smith PB, Hornik CP, Lang JE, Laughon MM. Association between postmenstrual age and furosemide dosage practices in very preterm infants. Journal of Perinatology. 2022 Jan 24. Epub ahead of print. PMID: 35075306 PMCID: PMC9007841 DOI: 10.1038/s41372-022-01320-w.

• Congenital anomalies of the kidney and urinary tract in critically ill infants

Leow EH, Lee JH, Hornik CP, Ng YH, Hays T, Clark RH, Tolia VN, and Greenberg RG. Congenital anomalies of the kidney and urinary tract (CAKUT) in critically ill infants: A multicentre cohort study. Pediatric Nephrology 2022 Apr 25. Epub ahead of print. PMID: 35467155 DOI: 10.1007/s00467-022-05542-0.

• Treatment of neonatal hyperglycemia in premature infants

Titchiner D, Hornik C, Benjamin R, Tolia V, Smith PB and Greenberg RG. Insulin for treatment of neonatal hyperglycemia in premature infants: Prevalence over time and association with outcomes. American Journal of Perinatology. 2022. PMID: 36356594 DOI: 10.1055/a-1976-2142.

• Antibiotic safety and effectiveness in preterm infants with cIAI

Smith MJ, Boutzoukas A, Autmizguine J, Hudak ML, Zinkhan E, Bloom BT, Heresi G, Lavery AP, Courtney SE, Sokol GM, Cotten CM, Bliss JM, Mendley S, Bendel C, Dammann CEL, Weitkamp JH, Saxonhouse MA, Mundakel GT, Debski J, Sharma G, Erinjeri J, Gao J, Benjamin DK Jr, Hornik CP, Smith PB, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee. Antibiotic Safety and Effectiveness in Premature Infants with Complicated Intraabdominal Infections. Pediatric Infectious Disease Journal. June 2021;40(6):550-555. PMID: 33902072 PMCID: PMC9844130 DOI: 10.1097/INF.0000000000003034.

• Safety of sildenafil in ELBW infants

Jackson W, Gonzalez D, Smith PB, Ambalavanan N, Atz AM, Sokol GM, Hornik CD, Stewart D, Mundakel G, Poindexter BB, Ahlfeld SK, Mills M, Cohen-Wolkowiez M, Martz K, Hornik CP, Laughon MM, & Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee. Safety of Sildenafil in Extremely Premature Infants: a Phase I Trial. Journal of Perinatology. January 2022;42(1):31-36. PMC856983.

• Acyclovir in treatment of neonatal HSV disease

Ericson JE, Benjamin DK Jr, Boakye-Agyeman F, Balevic SJ, Cotten CM, Adler-Shohet F, Laughon M, Poindexter B, Harper B, Payne EH, Kaneshige K, and Smith PB; Best Pharmaceuticals for Children Act - Pediatric Trials Network. Exposure-safety Relationship for Acyclovir in the Treatment of Neonatal Herpes Simplex Virus Disease. Early Human Development. July 2022;170:105616. PMID: 35763957 PMCID: PMC9645023 (available on 2023-07-01) DOI: 10.1016/j.earlhumdev.2022.105616.

• Severe congenital syphilis in the NICU

S. Aleem, L.S. Walker, C.D. Hornik, M.J. Smith, C.A. Grotegut, K.E.D. Weimer. Severe Congenital Syphilis in the Neonatal Intensive Care Unit – A Retrospective Case Series. Pediatr Infect Dis J. 2022 Apr 1;41(4):335-339. DOI: 10.1097/INF.0000000000003370. Epub ahead of print. PMID: 34620796. DOI: 10.1097/INF.0000000000003370.

• Breast milk and saliva for postnatal CMV screening among VLBW infants

S. Mukhopadhyay, H.L. Itell, E. Hartman, E. Woodford, M.B. Dhudasia, J.T. Steppe, S. ValenciaK.C. Wade, K.E.D. Weimer, S.R. Permar, K.M. Puopolo. Breast Milk and Saliva for Postnatal Cytomegalovirus Screening among Very Low Birth Weight Infants.  Pediatr Infect Dis J. 2022 Nov 1;41(11):904-910. doi: 10.1097/INF.0000000000003671. Epub 2022 Aug 23. PMID: 36102681.

• Pk and safety of ceftobiprole in pediatric patients

Rubino CM, Polak M, Schröpf S, Münch HG, Smits A, Cossey V, Tomasik T, Kwinta P, Snariene R, Liubsys A, Gardovska D, Hornik CD, Bosheva M, Ruehle C, Litherland K, Hamed K. Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients. Pediatr Infect Dis J. 2021 Nov 1;40(11):997-1003. doi: 10.1097/INF.0000000000003296. PMID: 34533489; PMCID: PMC8505155.

• Exposure-safety for acyclovir in the treatment of neonatal HSV disease

Ericson JE, Benjamin DK Jr, Boakye-Agyeman F, Balevic SJ, Cotten CM, Adler-Shohet F, Laughon M, Poindexter B, Harper B, Payne EH, Kaneshige K, Smith PB; Best Pharmaceuticals for Children Act - Pediatric Trials Network. Exposure-safety relationship for acyclovir in the treatment of neonatal herpes simplex virus disease. Early Hum Dev. 2022 Jul;170:105616. doi: 10.1016/j.earlhumdev.2022.105616. Epub 2022 Jun 22. PMID: 35763957.

• Blood myo-inositol concentrations in preterm and term infants

Brion LP, Phelps DL, Ward RM, Nolen TL, Hallman NMK, Das A, Zaccaro DJ, Ball MB, Watterberg KL, Frantz ID 3rd, Cotten CM, Poindexter BB, Oh W, Lugo RA, Van Meurs KP, O'Shea TM, Zaterka-Baxter KM, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Blood myo-inositol concentrations in preterm and term infants. J Perinatol. 2021 Feb;41(2):247-254. doi: 10.1038/s41372-020-00799-5. Epub 2020 Sep 15. PMID: 32934363; PMCID: PMC7889639.

JP, Ward EA, Williams TR, Blount JP, Wiener JS. Neurosurgical procedures for children with myelomeningocele after fetal or postnatal surgery: a comparative effectiveness study. Dev Med Child Neurol. 2021 Jan 2. doi: 10.1111/dmcn.14792. Epub ahead of print. PMID: 33386749.

Neonatal Opioid Withdrawal Syndrome (NOWS)

• ESC for NOWS: function-based assessment and management approach

Young LW, Ounpraseuth S, Merhar SL, Simon AE, Das A, Greenberg RG, Higgins RD, Lee J, Poindexter BB, Smith PB, Walsh M, Snowden J, Devlin LA, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network and the NIH Environmental influences on Child Health Outcomes (ECHO) Program Institutional Development Awards States Pediatric Clinical Trials Network. Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial. BMC Trials. 2022 Aug 9;23(1):638. PMID: 35945598 PMCID: PMC9361241 DOI: 10.1186/s13063-022-06445-z.

• Variation in the characteristics and care of infants with NOWs

Young LW, Hu Z, Annett RD, Das A, Fuller JF, Higgins RD, Lester BM, Merhar S, Simon AE, Ounprasueth S., Smith PB, Crawford MM, Atz AM, Cottrell LE, Cynski AJ, Newman S, Paul DA, Sanchez PJ, Semmens EO, Smith MC, Turley CB, Whalen BL, Poindexter BB, Snowden JN, Devlin LA. Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal. Pediatrics. January 2021;147(1):e2020008839. PMC7780957 DOI: 10.1542/peds.2020-008839

• Phenobarbital and clonidine as secondary medications for NOWs

Merhar SL, Ounpraseuth S, Devlin LA, Poindexter BB, Young LW, Berkey SD, Crowley M, Czynski AJ, Kiefer AS. Whalen BL, Das A, Fuller JF, Higgins RD, Thormbre V, Lester BM, Smith PB, Newman S, Sanchez PJ, Smith CM, Simon AE, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network and the NIH Environmental influences on Child Health Outcomes (ECHO) Program Institutional Development Awards States Pediatric Clinical Trials Network. Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome. Pediatrics. March 2021;147 ;147(3):e2020017830. PMC7919109 DOI: 10.1542/peds.2020-017830.

• Relationship between antenatal opioid agonist exposure and severity of NOWs

Devlin LA, Hu Z, Ounpraseuth S, Simon AE, Annett RD, Das A, Fuller JF, Higgins RD, Merhar SL, Smith PB, Crawford MM, Cottrell LE, Czynski AJ, Newman S, Paul DA, Sanchez PJ, Semmens EO, Smith C, Whalen BL, Snowden JN, Young LW, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network and the NIH Environmental influences on Child Health Outcomes (ECHO) Program Institutional Development Awards States Pediatric Clinical Trials Network. The Influence of Mediators on the Relationship between Antenatal Opioid Agonist Exposure and the Severity of Neonatal Opioid Withdrawal Syndrome. Maternal Child Health Journal, 2023 Mar 11.doi: 10.1007/s10995-022-03521-3.

Surgical Issues

• Neurosurgical procedures for children with myelomeningocele after fetal or postnatal surgery

Worley G, Greenberg RG, Rocque BG, Liu T, Dicianno BE, Castillo JP, Ward EA, Williams TR, Blount JP, Wiener JS. Neurosurgical procedures for children with myelomeningocele after fetal or postnatal surgery: a comparative effectiveness study. Developmental Medicine & Child Neurology. 2021 Nov;63(11):1294-1301. PMC8603138.

• Initial laparotomy versus peritoneal drainage in ELBW infants with NEC or perforation

Blakely ML, Tyson JE, Lally KP, Hintz SR, Eggleston B, Stevenson DK, Besner GE, Das A, Ohls RK, Truog WE, Nelin LD, Poindexter BB, Pedroza C, Walsh MC, Stoll BJ, Geller R, Kennedy KA, Dimmitt RA, Carlo WA, Cotten CM, Laptook AR, Van Meurs KP, Calkins KL, Sokol GM, Sanchez PJ, Wyckoff MH, Patel RM, Frantz ID 3rd, Shankaran S, D'Angio CT, Yoder BA, Bell EF, Watterberg KL, Martin CA, Harmon CM, Rice H, Kurkchubasche AG, Sylvester K, Dunn JCY, Markel TA, Diesen DL, Bhatia AM, Flake A, Chwals WJ, Brown R, Bass KD, St Peter SD, Shanti CM, Pegoli W Jr, Skarda D, Shilyansky J, Lemon DG, Mosquera RA, Peralta-Carcelen M, Goldstein RF, Vohr BR, Purdy IB, Hines AC, Maitre NL, Heyne RJ, DeMauro SB, McGowan EC, Yolton K, Kilbride HW, Natarajan G, Yost K, Winter S, Colaizy TT, Laughon MM, Lakshminrusimha S, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health, Human Development Neonatal Research Network. Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial. Ann Surg. 2021 Oct 1;274(4):e370-e380. doi: 10.1097/SLA.0000000000005099. PMID: 34506326; PMCID: PMC8439547.

• Perioperative drugs and doses used in inguinal hernia repairs for preterm infants

Dorismond C, Hunter S, McNaull P, Zimmerman KO, Benjamin DK, Greenberg RG, Laughon MM, Jackson W. Wide range of perioperative drugs and doses used in inguinal hernia repairs for premature infants. Journal of Perinatology. 2021 Mar;41(3):577-581. PMC7954820.

Long-term Outcomes

• Association between hyperbilirubinemia and hearing screen failure in preterm infants

Singh A, Francis HW, Smith PB, Clark RH, and Greenberg RG. Association between hyperbilirubinemia and hearing screen failure in the neonatal intensive care unit in infants born preterm. Journal of Pediatrics. 2021 Apr;231:68-73.

• Outcomes in neonatal LOS and late-onset culture-negative infection

Mukhopadhyay S, Puopolo K, Hansen NI, Lorch SA, DeMaura SB, Greenberg RG, Cotten CM, Sanchez PJ, Bell EF, Eichenwald EC, Stoll BJ, on behalf of the NICHD Neonatal Research Network. Neurodevelopmental outcomes in Neonatal Late-Onset Sepsis and Late-Onset Culture-Negative Infection. Archives of Disease in Childhood. 2021 Sep;106(5):467-473. PMC8292446.

• Group B strep infection in ELBW infants and neurodevelopmental outcomes

Puopolo KM, Mukhopadhyay S, Hansen NI, Flannery DD, Greenberg RG, Sanchez PJ, Bell EF, DeMauro SB, Wyckoff MH, Eichenwald EC, Stoll BJ. Group B Streptococcal Infection in Extremely Preterm Neonates and Neurodevelopmental Outcomes at 2 Years. Clinical Infectious Diseases. 2022 Mar 22. Epub ahead of print. 2022 Oct 12;75(8):1405-1415. doi: 10.1093/cid/ciac222.

• Longitudinal medical needs for periviable NICU survivors

Adams WA, Malcolm W, Goldstein R, Lemmon ME, Mago-Shah D, Cotten M, Peterson J, Fisher K, Younge N. Longitudinal medical needs for periviable NICU survivors. Early Hum Dev. 2022 Jun;169:105580. doi: 10.1016/j.earlhumdev.2022.105580. Epub 2022 May 8. PMID: 35569179; PMCID: PMC9627457.

• Antenatal steroid exposure at 21 to 22 weeks gestation and neonatal survival

Chawla S, Wyckoff MH, Rysavy MA, Patel RM, Chowdhury D, Natarajan G, Laptook AR, Lakshminrusimha S, Bell EF, Shankaran S, Van Meurs KP, Ambalavanan N, Greenberg RG, Younge N, Werner EF, Das A, Carlo WA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association of Antenatal Steroid Exposure at 21 to 22 Weeks of Gestation With Neonatal Survival and Survival Without Morbidities. JAMA Netw Open. 2022 Sep 1;5(9):e2233331. doi: 10.1001/jamanetworkopen.2022.33331. PMID: 36156145.

[The sections below are currently under construction.]

• Neurodevelopmental outcomes following LOS

Mukhopadhyay S, Puopolo KM, Hansen NI, Lorch SA, DeMauro SB, Greenberg RG, Cotten CM, Sanchez PJ, Bell EF, Eichenwald EC, Stoll BJ; NICHD Neonatal Research Network. Neurodevelopmental outcomes following neonatal late-onset sepsis and blood culture-negative conditions. Arch Dis Child Fetal Neonatal Ed. 2021 Jan 21:fetalneonatal-2020-320664. doi: 10.1136/archdischild-2020-320664. Epub ahead of print. PMID: 33478957; PMCID: PMC8292446.

Genetics

• Genetic variants associated with PDA in ELBWs

Dagle JM, Ryckman KK, Spracklen CN, Momany AM, Cotten CM, Levy J, Page GP, Bell EF, Carlo WA, Shankaran S, Goldberg RN, Ehrenkranz RA, Tyson JE, Stoll BJ, Murray JC; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. . Perinatol. 2019 Mar;39(3):401-408. doi: 10.1038/s41372-018-0285-6.

• Genetic variation in dopamine neurotransmission and motor development

Worley G, Erickson SW, Gustafson KE, Nikolova YS, Ashley-Koch AE, Belsky DW, Goldstein RF, Page GP, Cotten CM; Genetic variation in dopamine neurotransmission and motor development of infants born extremely-low-birthweight. Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Dev Med Child Neurol. 2020 Jun;62(6):750-757.

• Genetic predictors of severe IVH in ELBW infants

Thornburg CD, Erickson SW, Page GP, Clark EAS, DeAngelis MM, Hartnett ME, Goldstein RF, Dagle JM, Murray JC, Poindexter BB, Das A, Cotten CM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Genetic predictors of severe intraventricular hemorrhage in extremely low-birthweight infants. J Perinatol. 2021 Feb;41(2):286-294. doi: 10.1038/s41372-020-00821-w. Epub 2020 Sep 25. Erratum in: J Perinatol. 2020 Oct 12;: PMID: 32978526; PMCID: PMC7889697.

Palliative Care

• Withholding or withdrawing life-sustaining treatment in ELBW neonates

Dworetz AR, Natarajan G, Langer J, Kinlaw K, James JR, Bidegain M, Das A, Poindexter B, Bell EF, Cotten CM, Kirpalani H, Shankaran S, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health; Human Development Neonatal Research Network. Withholding or withdrawing life-sustaining treatment in extremely low gestational age neonates. Arch Dis Child Fetal Neonatal Ed. 2021 May;106(3):238-243. doi: 10.1136/archdischild-2020-318855. Epub 2020 Oct 20. PMID: 33082153; PMCID: PMC8055718.

• Delivery room death: A physician’s perspective

Bernstein SM. Acad Pediatr. 2020 Apr;20(3):293-294.

• Deciding when a life is not worth living

Lemmon ME. Deciding when a life is not worth living: An imperative to measure what matters. J Med Ethics. 2020 Jan;46(1):18-19. doi: 10.1136/medethics-2019-105807. Epub 2019 Nov 20. PMID: 31748207.

Technology in the NICU

• Augmented reality-assisted video laryngoscopy and simulated neonatal intubations

Dias PL. Greenberg RG, Goldberg RN, Fisher K, Tanaka DT: Augmented Reality–Assisted Video Laryngoscopy and Simulated Neonatal Intubations: A Pilot Study, Pediatrics March 2021, 147 (3) e2020005009.

• Point of care blood glucose meter system in intensive care setting

Nichols J, Brandler E,  Fantz C R,  Fisher K, Goodman M,  Headden G, Hoppensteadt D,  Ryan Matika R, Peacock W,  Rodrigo J, Schu¨tzenmeister A,  Swanson J, Canada-Vilalta C,  Miles G,  Tran N, A Multicenter Evaluation of a Point-of-Care Blood Glucose Meter System in Critically Ill Patients, The Journal of Applied Laboratory Medicine on 10 April 2021.

Healthcare System Management/Research

• Response of trial innovation network to COVID-19 pandemic

Greenberg RG, Poole L, Ford DE, Hanley D, Selker HP, Lane K, Dean JM, Burr J, Harris P, Wilkins CH, Bernard G, Edwards T, Benjamin DK Jr. Response of the trial innovation network to the COVID-19 pandemic. J Clin Transl Sci. 2021 Apr 20;5(1):e100. doi: 10.1017/cts.2021.782. PMID: 34192055; PMCID: PMC8185427.

• Telehealth transformation: COVID-19

Wosik J, Fudim M, Cameron B, Gellad ZF, Cho A, Phinney D, Curtis S, Roman M, Poon EG, Ferranti J, Katz JN, Tcheng J J Am Med Inform Assoc. 2020 Apr 20:ocaa067. doi: 10.1093/jamia/ocaa067.

Bench Science

• Stimulation-responsive chromatin across diverse human immune cells

Calderon D, Nguyen MLT, Mezger A, Kathiria A, Müller F, Nguyen V, Lescano N, Wu B, Trombetta J, Ribado JV, Knowles DA, Gao Z, Blaeschke F, Parent AV, Burt TD, Anderson MS, Criswell LA, Greenleaf WJ, Marson A, Pritchard JK. Landscape of Stimulation-Responsive Chromatin Across Diverse Human Immune Cells. Nat Genet 2019 Oct;51(10):1494-1505.

• Helios enhances preferential differentiation of human fetal CD4+ naïve T cells into regulatory T cells

Ng MSF, Roth TL, Mendoza VF, Marson A, Burt TD. Helios enhances the preferential differentiation of human fetal CD4+ naïve T cells into regulatory T cells.  Sci Immunol. 2019 Nov 22;4(41):eaav5947. doi: 10.1126/sciimmunol.aav5947.

• Fetal exposure to maternal microbiota in humans and mice

Younge N, McCann JR, Ballard J, Plunkett C, Akhtar S, Araújo-Pérez F, Murtha A, Brandon D, Seed PC. Fetal Exposure to the Maternal Microbiota in Humans and Mice.  JCI Insight. 2019 Oct 3;4(19):e127806. doi: 10.1172/jci.insight.127806.

Medical Education

• Challenges of e-Learning for the graduate medical education

Gray MM, Dadiz R, Izatt S, Gillam-Krakauer M, Carbajal MM, Falck AJ, Bonachea EM, Johnston LC, Karpen H, Vasquez MM, Chess PR, French H. Value, Strengths, and Challenges of e-Learning Modules Paired with the Flipped Classroom for Graduate Medical Education: A Survey from the National Neonatology Curriculum.  Am J Perinatol. 2020 Apr 10. doi: 10.1055/s-0040-1709145. [Online ahead of print]

• Flipped classroom curriculum for graduate medical education

Izatt S, Gray M, Dadiz R, French H. Development and Implementation of a National Neonatology Flipped Classroom Curriculum J Grad Med Educ. 2019 Jun;11(3):335-336.

Global Health

• Global health training during neonatal fellowship

Rent S, Valentine G, Ehret D, Kukora S. Global Health Training During Neonatal Fellowship: Fellow and Program Director Perspectives. J Perinatol. 2020 Aug;40(8):1253-1261.doi: 10.1038/s41372-020-0639-8. Epub 2020 Mar 9.

• Interactive behaviors of mothers with their infants in Malawi

Gondwe KW, Brandon D, Yang Q, Malcolm WF, Small MJ, Holditch-Davis D. An Observational Study on Early Dyadic Interactive Behaviors of Mothers With Early-Preterm, Late-Preterm, and Full-Term Infants in Malawi.   Adv Neonatal Care. 2020 Feb;20(1):90-99.

Academic Setting

• Navigating mid-career transition to academic medicine

Hannon E, Fisher, K, Seashore C, Tuccero D: Toto, I’ve a Feeling We’re Not in Kansas Anymore: Navigating the Mid-career Transition to Academic Medicine, Medical Science Educator, October 5, 2020. doi: 10.1007/s40670-020-01111-y.

If you currently have a baby in the Duke Intensive Care Nursery, and you think you may want to participate in any of our research studies, please ask your baby’s nurse or doctor to contact us. The NPRU team will then contact you to explain the criteria for study eligibility and describe the potential benefits and risks for entering the study. 

Riley Ashley
NPRU Graduate

To learn more about the Duke Intensive Care Nursery, visit the Duke Division of Neonatology website. For more information about the Neonatal Perinatal Research Unit or to learn more about our clinical trials, email us at npru@duke.edu, or call 919-681-4913.