Hydrocortisone for BPD

• ClinicalTrials.gov Identifier: NCT01353313
• Recruitment Status: Active, not recruiting
• First Posted: May 13, 2011
• Results First Posted: August 19, 2022
• Last Update Posted: August 19, 2022
• Sponsor: NICHD Neonatal Research Network
• Collaborators: National Center for Research Resources (NCRR); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Heart, Lung, and Blood Institute (NHLBI); National Center for Advancing Translational Sciences (NCATS)
• Information provided by (Responsible Party): NICHD Neonatal Research Network

Study Description

Brief Summary:

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.

Condition or disease	Intervention/treatment	Phase
Infant, Newborn; Infant, Small for Gestational Age; Infant, Very Low Birth Weight; Infant, Premature; Bronchopulmonary Dysplasia	Drug: Hydrocortisone; Drug: Placebo	Phase 3

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: A Randomized Controlled Trial of the Effect of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22 - 26 Months of Age in Intubated Infants < 30 Weeks Gestation Age
• Actual Study Start Date: August 11, 2011
• Actual Primary Completion Date: September 21, 2020
• Estimated Study Completion Date: January 2025

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Saline placebo	Drug: Placebo; 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
Experimental: Hydrocortisone; 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)	Drug: Hydrocortisone; 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

Outcome Measures

Primary Outcome Measures :

1. Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) [ Time Frame: 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.
2. Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) [ Time Frame: 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 Outcome Measures :

1. Number of Participants With Successful Extubation [ Time Frame: 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.
2. Total Deaths Before Discharge [ Time Frame: 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.
3. Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age [ Time Frame: 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
4. Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA) [ Time Frame: From birth to 36 weeks postmenstrual age ]
   Number of days on mechanical ventilation (using high frequency ventilator or conventional ventilator)
5. Duration of Oxygen Supplementation up to Status [ Time Frame: 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
6. Length of Hospital Stay in Days Among Survivors to Discharge [ Time Frame: From birth up to one year ]
   Number of days infant stayed in hospitals, among those who survived to discharge
7. Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA) [ Time Frame: From birth to 36 weeks postmenstrual age ]
   Infant received dexamethasone anytime before 36 weeks postmenstrual age.
8. Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI [ Time Frame: 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))

9. Number of Participants With Gross Motor Function Greater Than or Equal to Level 2 [ Time Frame: 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)
10. Number of Participants With Moderate-severe Cerebral Palsy [ Time Frame: 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).
11. Number of Participants With Severe Hearing Impairment (by Report) [ Time Frame: At 22-26 months corrected age ]
    Number of infants with bilateral hearing impairment with or without amplification (by report)
12. Number of Participants With no/Some Functional Vision [ Time Frame: At 22-26 months corrected age ]
    Number of infants with severe vision impairment in both eyes (consistent with refraction less than 20-200)
13. Weight Growth Measure Following Extremely Preterm Birth [ Time Frame: 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.
14. Follow-up Weight Growth Measure Following Extremely Preterm Birth [ Time Frame: 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.
15. Length Growth Measure Following Extremely Preterm Birth [ Time Frame: 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.
16. Follow-up Length Growth Measure Following Extremely Preterm Birth [ Time Frame: 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.
17. Head Circumference Growth Measure Following Extremely Preterm Birth [ Time Frame: 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.
18. Follow-up Head Circumference Growth Measure Following Extremely Preterm Birth [ Time Frame: 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.
19. Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade 40 Weeks Postmenstrual Age [ Time Frame: 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
20. Days of Mechanical Ventilation up to Status [ Time Frame: 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
21. Duration of Oxygen Supplementation Among Survivors to 36 Weeks [ Time Frame: From birth to 36 weeks postmenstrual age ]
    Number of days of oxygen supplementation from birth to 36 weeks post menstrual age
22. Duration of Invasive Positive Pressure Ventilation (PPV) After Postnatal Day 14 [ Time Frame: 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
23. Duration of Non-invasive Positive Pressure Ventilation (PPV) (Nasal IPPV/CPAP) After Postnatal Day 14 [ Time Frame: 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
24. Number of Participants Who Received Inhaled Glucocorticoids During Study Period [ Time Frame: From randomization to day 14 post randomization ]
    Number of infants who received Inhaled glucocorticoids during the study intervention period
25. Number of Participants Who Received Other Systemic Glucocorticoids During Study Period [ Time Frame: From randomization to day 14 post randomization ]
    Number of infants who received other systemic glucocorticoids during the study intervention period
26. Number of Days Dexamethasone Given Before 36 Weeks PMA [ Time Frame: From birth to 36 weeks postmenstrual age ]
    Number of days infant received dexamethasone anytime before 36 weeks postmenstrual age.
27. Number of Participants With Patent Ductus Arteriosus (PDA) Treated With Medication or Surgery [ Time Frame: 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
28. Number of Participants Diagnosed With Necrotizing Enterocolitis (NEC) [ Time Frame: 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)
29. Number of Participants With Retinopathy of Prematurity (ROP) Stage 3 or Worse [ Time Frame: 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.
30. Number of Participants Receiving Therapy for Retinopathy of Prematurity (ROP) [ Time Frame: 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)
31. Number of Participants With Severe Intraventricular Hemorrhage (IVH) [ Time Frame: 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.
32. Number of Participants With Periventricular Leukomalacia [ Time Frame: 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
33. Number of Participants With Neurodevelopmental Impairment (NDI) [ Time Frame: 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).
34. Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 85 [ Time Frame: 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.
35. Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 70 [ Time Frame: 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.
36. Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 85 [ Time Frame: 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.
37. Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 70 [ Time Frame: 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.
38. Number of Participants With Any Cerebral Palsy [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: up to 30 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

United States, California

University of California - Los Angeles

Los Angeles, California, United States, 90025

Stanford University

Palo Alto, California, United States, 94304

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30303

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Michigan

Wayne State University

Detroit, Michigan, United States, 48201

United States, Missouri

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

United States, New Mexico

University of New Mexico

Albuquerque, New Mexico, United States, 87131

United States, New York

University of Rochester

Rochester, New York, United States, 14642

United States, North Carolina

RTI International

Durham, North Carolina, United States, 27705

Duke University

Durham, North Carolina, United States, 27710

United States, Ohio

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States, 45267

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States, 44106

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

United States, Pennsylvania

Univeristy of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Rhode Island

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States, 02905

United States, Texas

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States, 75235

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84108

Sponsors and Collaborators

NICHD Neonatal Research Network

National Center for Research Resources (NCRR)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Heart, Lung, and Blood Institute (NHLBI)

National Center for Advancing Translational Sciences (NCATS)

Investigators

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

  Study Documents (Full-Text)

Documents provided by NICHD Neonatal Research Network:

Study Protocol and Statistical Analysis Plan  [PDF] August 27, 2013

More Information

Additional Information:

NICHD Neonatal Research Network site 

NICHD Pregnancy & Perinatology Branch 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: NICHD Neonatal Research Network
• ClinicalTrials.gov Identifier: NCT01353313
• Other Study ID Numbers: NICHD-NRN-0045; U10HD034216 ( U.S. NIH Grant/Contract ); U10HD027904 ( U.S. NIH Grant/Contract ); U10HD021364 ( U.S. NIH Grant/Contract ); U10HD027853 ( U.S. NIH Grant/Contract ); U10HD040689 ( U.S. NIH Grant/Contract ); U10HD040492 ( U.S. NIH Grant/Contract ); U10HD027851 ( U.S. NIH Grant/Contract ); U10HD021373 ( U.S. NIH Grant/Contract ); U10HD027856 ( U.S. NIH Grant/Contract ); U10HD053109 ( U.S. NIH Grant/Contract ); U10HD036790 ( U.S. NIH Grant/Contract ); U10HD027880 ( U.S. NIH Grant/Contract ); U10HD053089 ( U.S. NIH Grant/Contract ); U10HD021385 ( U.S. NIH Grant/Contract ); U10HD068244 ( U.S. NIH Grant/Contract ); U10HD068263 ( U.S. NIH Grant/Contract ); U10HD068270 ( U.S. NIH Grant/Contract ); U10HD068278 ( U.S. NIH Grant/Contract ); U10HD068284 ( U.S. NIH Grant/Contract ); U24HL137729 ( U.S. NIH Grant/Contract ); 1UG3HL137872 ( U.S. NIH Grant/Contract )
• First Posted: May 13, 2011
• Results First Posted: August 19, 2022
• Last Update Posted: August 19, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov)

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NICHD Neonatal Research Network:

NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Very Low Birth Weight (VLBW); Prematurity; Mechanical ventilation; Intubation; Neurodevelopmental impairment

Additional relevant MeSH terms:

Bronchopulmonary Dysplasia; Birth Weight; Body Weight; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Hydrocortisone; Anti-Inflammatory Agents