Phase 3 N=800 Randomized Triple-blind Prevention

Hydrocortisone for BPD

Infant, Newborn · Infant, Small for Gestational Age · Infant, Very Low Birth Weight · Infant, Premature · Bronchopulmonary Dysplasia

Bottom Line

View on ClinicalTrials.gov: NCT01353313 ↗

Enrolled (actual)

800

Serious AEs

22.4%

Results posted

Aug 2022

Primary outcome: Primary: Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD) — 332; 349; 66; 53 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Hydrocortisone (Drug); Placebo (Drug)
Age: Pediatric
Sex: All
Sponsor: NICHD Neonatal Research Network
Primary completion: Sep 2020

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01353313). 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.