Hydrocortisone for BPD

Bronchopulmonary dysplasia (BPD) remains a leading morbidity of the extremely preterm infant, and prolonged mechanical ventilation is associated with increased risk for BPD. Dexamethasone has been used previously to facilitate extubation and decrease the incidence of BPD; however, due to adverse effects on neurodevelopmental outcomes, the use of this drug has decreased. One cohort study suggests that hydrocortisone (HC) may facilitate extubation. HC has thus far not been associated with adverse neurodevelopmental outcomes in either cohort studies or randomized controlled trials. A recent meta-analysis of postnatal corticosteroid therapy begun after the first week of life suggested that "late therapy may reduce neonatal mortality without significantly increasing the risk of adverse long-term neurodevelopmental outcomes," although the methodological quality of some of the follow-up was acknowledged to be limited.

This is a randomized controlled trial to study the efficacy and safety of a 10-day tapering course of hydrocortisone treatment for infants <30 weeks estimated gestational age at birth who remain intubated at 14 - 28 days postnatal age. Based on previous Network data these criteria define a population with a risk of death or BPD at 36 weeks postmenstrual age of approximately 65 - 75%. The primary outcome for this study will incorporate both (1) survival without moderate to severe BPD by Network physiologic definition and (2) survival without moderate or severe NDI at 18 - 22 months corrected age. Therefore, the results of this study will be reported only when follow-up data are available unless (1) the trial is stopped early by the DSMC because of strong evidence of benefit or harm, or (2) at the time all subjects have completed treatment the DCC finds a substantial survival benefit favoring hydrocortisone (p<0.001). Individual study assignment will remain masked until the follow-up is completed. Secondary outcomes will include short term measures such as respiratory morbidities and growth at 36 weeks postmenstrual age and long term measures including growth and other outcomes at 22 - 26 months corrected age.

Secondary studies include:

1. Effect of Hydrocortisone on the Cardiac mass of Premature Intubated Infants - will determine left ventricular mass index at 36 weeks postmenstrual age (or prior to discharge/transfer if after 34 weeks) in infants enrolled in the hydrocortisone for BPD RCT, and compare HC-treated infants to placebo-treated infants. It will similarly assess and compare the incidence of pulmonary hypertension in these patients.
2. Extended follow-up: Subjects will be seen for a follow-up visit at 5-6 years corrected age to assess functional developmental and respiratory outcomes at early school age. In a subset of five Neonatal Research Network Clinical Centers, impulse oscillometry (IOS), which is the optimal direct measure of lung capacity and function, will be performed to validate the 6-minute walk test and International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire as functional measures of pulmonary status. Also at these five Centers, the six minute walk test, ISAAAC questionnaire, and IOS will be administered as part of (1) the Healthy Lungs sub-study, which will recruit 120 TOP 5 study participants who had minimal lung disease when they were infants to define normative ranges in healthy, preterm-born children, and (2) the Healthy Lungs Two sub-study, which will recruit 120 healthy, term-born children without history of lung disease to characterize functional and mechanical respiratory outcomes at 5-7 years of age.

• Hydrocortisone (Drug): Hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents), to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows: 4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then 1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days
• Placebo (Drug): Saline placebo to be administered either intravenously or orally if no intravenous line is available, at the same dose, and tapered as follows: 4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then 1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days

Primary outcomes

• Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) [From day of randomization to 36 weeks post menstrual age]: Survival without moderate or severe physiologic BPD at 36 weeks postmenstrual age. Moderate or severe physiologic BPD is defined as a requirement for supplemental oxygen and/or positive airway pressure to maintain oxygen saturation greater than 90 percent. A room air challenge was performed for infants estimated to be receiving less than 0.30 FiO2 by nasal cannula.
• Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) [From day of randomization to 22-26 months corrected age]: Survival without moderate or severe neurodevelopmental impairment (NDI) at 22-26 months corrected age. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction from less than 20 to 200), or bilateral hearing impairment with or without amplification (by report).

Secondary outcomes

• Number of Participants With Successful Extubation [From day of randomization to day 14 post randomization]: Successful extubation during the intervention period, defined as remaining extubated for greater than or equal to 1 week, including greater than or equal to 3 days after the last dose of study medication. An extubation attempt was required after 72 hours of study drug and 24 hours after meeting the following: FiO2 less than 0.40 to maintain a saturation of greater than or equal to 88 percent, mean airway pressure less than 8 cm H2O, and hemodynamically stable in the opinion of the clinical team.
• Total Deaths Before Discharge [From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Infant died before discharge home.
• Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age [At 36 weeks postmenstrual age]: BPD grade at 36 weeks postmenstrual age. BPD grades are defined as: 1. No support/room air; 2. Nasal cannula (NC) O2 less than or equal to 2L; 3. NC O2 greater than 2L or CPAP/NIPPV; 4. Invasive PPV
• Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA) [From birth to 36 weeks postmenstrual age]: Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator)
• Duration of Oxygen Supplementation up to Status [From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Number of days of oxygen supplementation from birth to discharge home
• Length of Hospital Stay in Days Among Survivors to Discharge [From birth up to one year]: Number of days infant stayed in hospitals, among those who survived to discharge
• Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA) [From birth to 36 weeks postmenstrual age]: Infant received dexamethasone anytime before 36 weeks postmenstrual age.
• Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI [At 22-26 months corrected age]: Severity of neurodevelopmental impairment, defined as one or more of: Bayley Scales of Infant Development-III (Bayley-III) cognitive score <85 (standardized mean 100, SD 15, range 55-145), Bayley-III motor score <85 (standardized mean 100, range 45-155), Gross Motor Function Classification System (GMFCS) level ≥2, severe vision impairment in both eyes (consistent with refraction <20-200), or bilateral hearing impairment with or without amplification (by report). Bayley-III = Bayley Scales of Infant Development III (Cognitive score standardized mean 100, SD 15, range 55-145 motor score standardized mean 100, range 45-155; higher score indicates better performance (20))
• Number of Participants With Gross Motor Function Greater Than or Equal to Level 2 [At 22-26 months corrected age]: Number of infants with Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment)
• Number of Participants With Moderate-severe Cerebral Palsy [At 22-26 months corrected age]: Number of infants with moderate or severe grade of cerebral palsy. Cerebral Palsy was diagnosed when there were definite abnormalities observed in the neuromotor exam, and functional challenges as classified by GMFCS level, and classified as moderate if GMFCS level was II or III and severe if level IV or V (40).
• Number of Participants With Severe Hearing Impairment (by Report) [At 22-26 months corrected age]: Number of infants with bilateral hearing impairment with or without amplification (by report)
• Number of Participants With no/Some Functional Vision [At 22-26 months corrected age]: Number of infants with severe vision impairment in both eyes (consistent with refraction less than 20-200)
• Weight Growth Measure Following Extremely Preterm Birth [At 36 weeks post-menstrual age]: This is measured as the weight Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average weight, and negative scores denote less than average weight.
• Follow-up Weight Growth Measure Following Extremely Preterm Birth [At 22-26 months corrected age]: This is measured as the weight Z-score at 22-26 months corrected age. The Z-score is determined using the WHO weight-for-age chart, and is derived from a standardized normal distribution, where 0 designates average weight-for-age, and negative scores denote less than average weight-for-age.
• Length Growth Measure Following Extremely Preterm Birth [At 36 weeks post-menstrual age]: This is measured as the length Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average length, and negative scores denote less than average length.
• Follow-up Length Growth Measure Following Extremely Preterm Birth [At 22-26 months corrected age]: This is measured as the length Z-score at 22-26 months corrected age. The Z-score is determined using the WHO length-for-age chart, and is derived from a standardized normal distribution, where 0 designates average length-for-age, and negative scores denote less than average length-for-age.
• Head Circumference Growth Measure Following Extremely Preterm Birth [At 36 weeks post-menstrual age]: This is measured as the head circumference Z-score at 36 weeks postmenstrual age. The Z-score is derived using Fenton growth curves, and follows a standardized normal distribution with a mean 0. A z-score of 0 designates average head circumference, and negative scores denote less than average head circumference.
• Follow-up Head Circumference Growth Measure Following Extremely Preterm Birth [At 22-26 months corrected age]: This is measured as the head circumference Z-score at 22-26 months corrected age. The Z-score is determined using the WHO head circumference-for-age chart, and is derived from a standardized normal distribution, where 0 designates average head circumference-for-age, and negative scores denote less than average head circumference-for-age.
• Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade 40 Weeks Postmenstrual Age [At 40 weeks post menstrual age]: BPD grade at 40 weeks postmenstrual age. BPD grades are defined as: 1. No support/room air; 2. Nasal cannula (NC) O2 less than or equal to 2L; 3. NC O2 greater than 2L or CPAP/NIPPV; 4. Invasive PPV
• Days of Mechanical Ventilation up to Status [From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator) up to status
• Duration of Oxygen Supplementation Among Survivors to 36 Weeks [From birth to 36 weeks postmenstrual age]: Number of days of oxygen supplementation from birth to 36 weeks post menstrual age
• Duration of Invasive Positive Pressure Ventilation (PPV) After Postnatal Day 14 [From postnatal day 15 to 36 weeks post menstrual age or Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Number of days on invasive PPV after postnatal day 14
• Duration of Non-invasive Positive Pressure Ventilation (PPV) (Nasal IPPV/CPAP) After Postnatal Day 14 [From postnatal day 15 to 36 weeks post menstrual age or Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Number of days of non-invasive PPV after postnatal day 14
• Number of Participants Who Received Inhaled Glucocorticoids During Study Period [From randomization to day 14 post randomization]: Number of infants who received Inhaled glucocorticoids during the study intervention period
• Number of Participants Who Received Other Systemic Glucocorticoids During Study Period [From randomization to day 14 post randomization]: Number of infants who received other systemic glucocorticoids during the study intervention period
• Number of Days Dexamethasone Given Before 36 Weeks PMA [From birth to 36 weeks postmenstrual age]: Number of days infant received dexamethasone anytime before 36 weeks postmenstrual age.
• Number of Participants With Patent Ductus Arteriosus (PDA) Treated With Medication or Surgery [From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Number of infants with a Patent Ductus Arteriosus (PDA) that was treated with medicine or surgery
• Number of Participants Diagnosed With Necrotizing Enterocolitis (NEC) [From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Number of infants diagnosed with Necrotizing Enterocolitis (NEC)
• Number of Participants With Retinopathy of Prematurity (ROP) Stage 3 or Worse [From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Number of infants diagnosed with ROP stage 3 or worse in either eye. ROP stage 3 or worse is determined based on the extent of extraretinal fibrovascular proliferation. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease.
• Number of Participants Receiving Therapy for Retinopathy of Prematurity (ROP) [From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Number of infants receiving therapy for Retinopathy of prematurity (ROP)
• Number of Participants With Severe Intraventricular Hemorrhage (IVH) [From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Number of infants with severe IVH, grade 3 or 4. Severity of IVH is hierarchical. Grade 3 occurs when the ventricular size is enlarged and blood/echodensity is in the ventricle. Grade 4 occurs when blood/echodensity is in the parenchyma.
• Number of Participants With Periventricular Leukomalacia [From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth]: Number of infants with Periventricular leukomalacia
• Number of Participants With Neurodevelopmental Impairment (NDI) [At 22-26 months corrected age]: Number of infants with NDI. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction less than 20-200), or bilateral hearing impairment with or without amplification (by report).
• Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 85 [At 22-26 months corrected age]: Number of infants with a BSID-III cognitive composite score less than 85. (standardized mean 100, SD 15, range 55-145). Higher scores indicate better performance. Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.
• Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 70 [At 22-26 months corrected age]: Number of infants with a BSID-III cognitive composite score less than 70. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.
• Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 85 [At 22-26 months corrected age]: Number of infants with a BSID-III motor composite score less than 85. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 85 are less than 1 standard deviation below the mean of 100.
• Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 70 [At 22-26 months corrected age]: Number of infants with a BSID-III motor composite score less than 70. (standardized mean 100, SD 15, range 55-145). Composite BSID-III scores of less than 70 are less than 2 standard deviations below the mean of 100.
• Number of Participants With Any Cerebral Palsy [At 22-26 months corrected age]: Number of infants with cerebral palsy. Cerebral Palsy was diagnosed when there were definite abnormalities observed in the neuromotor exam, and functional challenges as classified by GMFCS level, and classified as moderate if GMFCS level was II or III and severe if level IV or V (40).

Sex: All, ages: any to 30 Weeks

Inclusion Criteria:

* infants <30 weeks estimated gestational age
* inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age
* have received at least 7days of mechanical ventilation;
* are receiving mechanical ventilation through an endotracheal tube .

Exclusion Criteria:

* Major congenital anomalies
* Decision to limit support
* Indomethacin or ibuprofen treatment within 48 hours of study drug
* Previous corticosteroid treatment for BPD
* Received hydrocortisone for 14 or more cumulative days
* Received hydrocortisone within 7 days of study entry

Participant flow

Outcome results

• Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) (Primary), Count of participants, Participants: Hydrocortisone 332; Placebo 349
• Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) (Primary), Count of participants, Participants: Hydrocortisone 226; Placebo 226
• Number of Participants With Successful Extubation (Secondary), Count of participants, Participants: Hydrocortisone 178; Placebo 135
• Total Deaths Before Discharge (Secondary), Count of participants, Participants: Hydrocortisone 35; Placebo 40
• Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age (Secondary), Count of participants, Participants: Hydrocortisone 63; Placebo 51
• Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA) (Secondary), Median, Days: Hydrocortisone 37 (27 to 54); Placebo 40 (30 to 55)
• Duration of Oxygen Supplementation up to Status (Secondary), Median, Days: Hydrocortisone 104.5 (84 to 120); Placebo 104 (83 to 120)
• Length of Hospital Stay in Days Among Survivors to Discharge (Secondary), Median, Days: Hydrocortisone 127.5 (104 to 158); Placebo 125.5 (106 to 155)
• Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA) (Secondary), Count of participants, Participants: Hydrocortisone 150; Placebo 157
• Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI (Secondary), Count of participants, Participants: Hydrocortisone 98; Placebo 98
• Number of Participants With Gross Motor Function Greater Than or Equal to Level 2 (Secondary), Count of participants, Participants: Hydrocortisone 283; Placebo 288
• Number of Participants With Moderate-severe Cerebral Palsy (Secondary), Count of participants, Participants: Hydrocortisone 41; Placebo 33
• Number of Participants With Severe Hearing Impairment (by Report) (Secondary), Count of participants, Participants: Hydrocortisone 319; Placebo 313
• Number of Participants With no/Some Functional Vision (Secondary), Count of participants, Participants: Hydrocortisone 325; Placebo 321
• Weight Growth Measure Following Extremely Preterm Birth (Secondary), Mean, Z-score: Hydrocortisone -1.68 +/- 1.01; Placebo -1.65 +/- 0.98
• Follow-up Weight Growth Measure Following Extremely Preterm Birth (Secondary), Mean, Z-score: Hydrocortisone -0.51 +/- 1.04; Placebo -0.44 +/- 1.15
• Length Growth Measure Following Extremely Preterm Birth (Secondary), Mean, Z-score: Hydrocortisone -2.33 +/- 1.16; Placebo -2.21 +/- 1.14
• Follow-up Length Growth Measure Following Extremely Preterm Birth (Secondary), Mean, Z-score: Hydrocortisone -0.93 +/- 1.17; Placebo -0.94 +/- 1.22
• Head Circumference Growth Measure Following Extremely Preterm Birth (Secondary), Mean, Z-score: Hydrocortisone -1.68 +/- 1.34; Placebo -1.74 +/- 1.17
• Follow-up Head Circumference Growth Measure Following Extremely Preterm Birth (Secondary), Mean, Z-score: Hydrocortisone -0.45 +/- 1.41; Placebo -0.35 +/- 1.42
• 20 more outcome measures not shown.

Adverse events

Time frame: Birth to 36 weeks PMA

Serious adverse events by term

Other adverse events by term

• Results publication: DeMauro SB, Kirpalani H, Hintz S, Watterberg KL, Watson V, Lowe J, Shankaran S, Chawla S, Vohr B, Msall ME, D'Angio CT, Yoder BA, Lai K, Winter S, Colaizy TT, Merhar SL, Ziolkowski K, Bann CM, Trotta M, Newman JE, Walsh MC, Higgins RD, Cahill TE, Duncan AF, Wilson-Costello DE, Peralta-Carcelen M, Arnold H, Mosquera RA, Heyne RJ, Fuller J, McGowan EC, Cavanaugh B, Harmon HM, Maitre NL, Neel ML, Van Meurs KP, Richards LA, Kilbride HW, Hines AC, Natarajan G, Trembath A, Benninger KL, Kesavan K, Malcolm WF, Zanger D, Reynolds AM, Carlson M, Das A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Hydrocortisone in Preterm Infants and School-Age Functional Outcomes: Follow-Up of a Randomized Clinical Trial. JAMA Pediatr. 2026 Feb 1;180(2):134-143. doi: 10.1001/jamapediatrics.2025.4801. PMID 41359352
• Results publication: Sankar MN, Chock V, Myers F, Davis AS, McDonald S, Rysavy MA, Laughon M, Bhombal S, Van Meurs KP, Das A, Benitz WE, Watterberg K; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Patent Ductus Arteriosus, Hydrocortisone, and Outcome among Infants Born Extremely Preterm: Secondary Analysis of the Hydrocortisone Trial. J Pediatr. 2025 Jun;281:114535. doi: 10.1016/j.jpeds.2025.114535. Epub 2025 Mar 14. PMID 40090543
• Results publication: DeMauro SB, Kirpalani H, Ziolkowski K, Hintz S, Watterberg K, Lowe J, Shankaran S, Chawla S, Vohr B, Msall M, D'Angio C, Yoder BA, Lai K, Winter S, Colaizy T, Merhar S, Bann CM, Trotta M, Newman J, Natarajan A, Das A. The HYdrocortisone for Bronchopulmonary Dysplasia Respiratory and Developmental (HYBRiD) outcomes study: protocol for a longitudinal cohort study. BMC Pediatr. 2024 Nov 14;24(1):737. doi: 10.1186/s12887-024-05198-9. PMID 39543521
• Results publication: Gentle SJ, Rysavy MA, Li L, Laughon MM, Patel RM, Jensen EA, Hintz S, Ambalavanan N, Carlo WA, Watterberg K; National Institute of Child Health and Human Development Neonatal Research Network. Heterogeneity of Treatment Effects of Hydrocortisone by Risk of Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants in the National Institute of Child Health and Human Development Neonatal Research Network Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315315. doi: 10.1001/jamanetworkopen.2023.15315. PMID 37256621
• Results publication: 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

• Study Protocol and Statistical Analysis Plan (PDF, 2013-08-27)
• Informed Consent Form (PDF, 2012-05-07)

• Michele C Walsh, MD, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's Hospital
• Seetha Shankaran, MD, Principal investigator, Wayne State University
• Abbot R Laptook, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode Island
• C. Michael Cotten, MD, Principal investigator, Duke University
• David Carlton, MD, Principal investigator, Emory University
• Greg Sokol, MD, Principal investigator, Indiana University
• Abhik Das, PhD, Principal investigator, RTI International
• Krisa P Van Meurs, MD, Principal investigator, Stanford University
• Brenda P Poindexter, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
• Waldemar A Carlo, MD, Principal investigator, University of Alabama at Birmingham
• Edward F Bell, MD, Principal investigator, University of Iowa
• Kristi L Watterberg, MD, Study chair, University of New Mexico
• Myra Wyckoff, MD, Principal investigator, University of Texas, Southwestern Medical Center at Dallas
• Jon E Tyson, MD, MPH, Principal investigator, The University of Texas Health Science Center, Houston
• Eric Eichenwald, MD, Principal investigator, University of Pennsylvania
• Carl T D'Angio, MD, Principal investigator, University of Rochester
• Uday Devaskar, MD, Principal investigator, University of California, Los Angeles
• Pablo J Sanchez, MD, Principal investigator, Research Institute at Nationwide Children's Hospital
• William Truog, MD, Principal investigator, Children's Mercy Hospital Kansas City
• Bradley Yoder, MD, Principal investigator, University of Utah

NIH grants: U10HD034216, U10HD027904, U10HD021364, U10HD027853, U10HD040689, U10HD040492, U10HD027851, U10HD021373, U10HD027856, U10HD053109, U10HD036790, U10HD027880, U10HD053089, U10HD021385, U10HD068244, U10HD068263, U10HD068270, U10HD068278, U10HD068284, U24HL137729, 1UG3HL137872