Phase 2
N=64
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
Bronchopulmonary Dysplasia · Encephalomalacia · Premature Birth
Bottom Line
View on ClinicalTrials.gov: NCT00167544 ↗Enrolled (actual)
64
Serious AEs
25.0%
Results posted
Aug 2013
Primary outcome: Primary: Total Cerebral Volume as Measured by Volumetric Brain MRI — 272.01; 277.82 cm^3
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hydrocortisone (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Nationwide Children's Hospital
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Cerebral Volume as Measured by Volumetric Brain MRI |
272.01; 277.82 | — |
| SECONDARY Regional Brain Volumes |
122.45; 118.62 | <0.05 sig |
| SECONDARY Duration of Positive Pressure Support (Mechanical Ventilation or Continuous Positive Airway Pressure) |
68.7; 65.9 | — |
| SECONDARY Duration of Oxygen Requirement |
72.7; 72.0 | — |
| SECONDARY Survival Without Severe Bronchopulmonary Dysplasia (BPD) |
3; 5 | — |
Summary
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
Eligibility Criteria
Inclusion Criteria
- Patient in the Memorial Hermann Children's Hospital (MHCH) neonatal intensive care unit with a birth weight ≤ 1000 grams.
- Ventilator-dependent between 10 and 21 days of age.
- Respiratory index score (RIS: mean airway pressure x fraction of inspired oxygen) of ≥ 2.0 that is increasing or stable for the previous 24 hours or a RIS ≥ 3.0 if improvement noted in the past 24 hours.
Exclusion Criteria
- Prior postnatal steroid treatment.
- Evidence of sepsis or necrotizing enterocolitis.
- Known major congenital anomalies of the cardiopulmonary or central nervous system.
- Infants being treated with indomethacin or those likely to require treatment in the next 7 days as judged by the treating physician.
- Inability or unwillingness of parent or legal guardian/representative to give written informed consent.
- Gestational age < 23 weeks.
Data sourced from ClinicalTrials.gov (NCT00167544). 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.