Phase 3
Completed N=800
Hydrocortisone for BPD
Infant, Newborn · Infant, Small for Gestational Age · Infant, Very Low Birth Weight · Infant, Premature
Source: ClinicalTrials.gov NCT01353313 ↗
Enrolled (actual)
800
Serious AEs
22.4%
Results posted
Aug 2022
Primary outcomePrimary: Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) — 332; 349; 66; 53 Participants
◆ Published Evidence
Highly cited
109citations · ~27 / year
Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia.
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.
Linked Publications (5)
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Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia.
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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.
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The HYdrocortisone for Bronchopulmonary Dysplasia Respiratory and Developmental (HYBRiD) outcomes study: protocol for a longitudinal cohort study.
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Hydrocortisone in Preterm Infants and School-Age Functional Outcomes: Follow-Up of a Randomized Clinical Trial.
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Patent Ductus Arteriosus, Hydrocortisone, and Outcome among Infants Born Extremely Preterm: Secondary Analysis of the Hydrocortisone Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) |
332; 349; 66; 53 | — |
| PRIMARY Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI) |
226; 226; 132; 134 | — |
| SECONDARY Number of Participants With Successful Extubation |
178; 135; 220; 267 | — |
| SECONDARY Total Deaths Before Discharge |
35; 40; 363; 362 | — |
| SECONDARY Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual Age |
63; 51; 152; 159; 120; 124 | — |
| SECONDARY Days of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA) |
37; 40 | — |
| SECONDARY Duration of Oxygen Supplementation up to Status |
104.5; 104 | — |
| SECONDARY Length of Hospital Stay in Days Among Survivors to Discharge |
127.5; 125.5 | — |
| SECONDARY Number of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA) |
150; 157; 229; 220 | — |
| SECONDARY Number of Participants With Normal/Mild, Moderate or Severe/Profound NDI |
98; 98; 132; 134; 85; 82 | — |
| SECONDARY Number of Participants With Gross Motor Function Greater Than or Equal to Level 2 |
283; 288; 48; 41 | — |
| SECONDARY Number of Participants With Moderate-severe Cerebral Palsy |
41; 33; 289; 297 | — |
| SECONDARY Number of Participants With Severe Hearing Impairment (by Report) |
319; 313; 9; 14 | — |
| SECONDARY Number of Participants With no/Some Functional Vision |
325; 321; 5; 9 | — |
| SECONDARY Weight Growth Measure Following Extremely Preterm Birth |
-1.68; -1.65 | — |
| SECONDARY Follow-up Weight Growth Measure Following Extremely Preterm Birth |
-0.51; -0.44 | — |
| SECONDARY Length Growth Measure Following Extremely Preterm Birth |
-2.33; -2.21 | — |
| SECONDARY Follow-up Length Growth Measure Following Extremely Preterm Birth |
-0.93; -0.94 | — |
| SECONDARY Head Circumference Growth Measure Following Extremely Preterm Birth |
-1.68; -1.74 | — |
| SECONDARY Follow-up Head Circumference Growth Measure Following Extremely Preterm Birth |
-0.45; -0.35 | — |
| SECONDARY Number of Participants With Bronchopulmonary Dysplasia (BPD) Grade 40 Weeks Postmenstrual Age |
46; 38; 73; 65; 124; 129 | — |
| SECONDARY Days of Mechanical Ventilation up to Status |
37; 41 | — |
| SECONDARY Duration of Oxygen Supplementation Among Survivors to 36 Weeks |
74; 73 | — |
| SECONDARY Duration of Invasive Positive Pressure Ventilation (PPV) After Postnatal Day 14 |
29; 27 | — |
| SECONDARY Duration of Non-invasive Positive Pressure Ventilation (PPV) (Nasal IPPV/CPAP) After Postnatal Day 14 |
13; 13 | — |
| SECONDARY Number of Participants Who Received Inhaled Glucocorticoids During Study Period |
345; 355; 51; 44 | — |
| SECONDARY Number of Participants Who Received Other Systemic Glucocorticoids During Study Period |
342; 334; 54; 65 | — |
| SECONDARY Number of Days Dexamethasone Given Before 36 Weeks PMA |
10; 10 | — |
| SECONDARY Number of Participants With Patent Ductus Arteriosus (PDA) Treated With Medication or Surgery |
206; 209; 192; 193 | — |
| SECONDARY Number of Participants Diagnosed With Necrotizing Enterocolitis (NEC) |
33; 46; 365; 356 | — |
| SECONDARY Number of Participants With Retinopathy of Prematurity (ROP) Stage 3 or Worse |
105; 116; 277; 260 | — |
| SECONDARY Number of Participants Receiving Therapy for Retinopathy of Prematurity (ROP) |
311; 293; 68; 83 | — |
| SECONDARY Number of Participants With Severe Intraventricular Hemorrhage (IVH) |
316; 331; 81; 71 | — |
| SECONDARY Number of Participants With Periventricular Leukomalacia |
376; 378; 22; 24 | — |
| SECONDARY Number of Participants With Neurodevelopmental Impairment (NDI) |
189; 185; 132; 134 | — |
| SECONDARY Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 85 |
168; 176; 150; 142 | — |
| SECONDARY Number of Participants With a Bayley Scales of Infant Development (BSID) Cognitive Composite Score Less Than 70 |
259; 269; 59; 49 | — |
| SECONDARY Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 85 |
164; 158; 146; 152 | — |
| SECONDARY Number of Participants With a Bayley Scales of Infant Development (BSID) Motor Composite Score Less Than 70 |
241; 246; 69; 64 | — |
| SECONDARY Number of Participants With Any Cerebral Palsy |
84; 71; 246; 259 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01353313) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.