Premature Birth Clinical Trial
Official title:
A Randomized Trial of Hydrocortisone in Very Preterm Infants at High Risk for Neurologic and Pulmonary Impairments
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.
Hypothesis: Among extremely low birth weight infants (ELBW; BW ≤ 1000 g) at high risk for
bronchopulmonary dysplasia (BPD) and neurologic impairments, those infants randomized to
seven days of hydrocortisone will demonstrate increased total cerebral tissue volumes as
compared to infants randomized to placebo.
Specific Aims: 1) To perform a pilot blinded randomized controlled trial of a 7-day regimen
of low dose hydrocortisone in ELBW infants at high risk for BPD and neurosensory impairments
and assess its effect on cerebral tissue volumes. 2) Evaluate and report 2 year
neurodevelopmental outcomes.
Background and Significance: Bronchopulmonary dysplasia is a disease of arrested lung
development and lung inflammation. It is primarily seen in ELBW infants. Neurological delay,
including cerebral palsy and mental retardation, affect up to 40%-50% of surviving ELBW
infants. BPD is an important risk factor for such neurological delay. Postnatal
administration of corticosteroids to ventilated preterm neonates results in a reduced risk
of developing BPD. Postnatal corticosteroids however have shown harmful effects on the brain
and can lead to increased rates of cerebral palsy and learning problems. This effect has
primarily been seen with dexamethasone when high doses were given in the first week of life.
Beyond the first week of life, there is insufficient information on the effects of steroids
on the brain. Steroids other than dexamethasone, in much lower doses have been shown to
improve short term lung function with minimal short-term side effects. A review study of all
steroid trials for BPD shows that when given to a high risk group of infants (> 50% risk of
BPD) steroids protect the brain and reduce rates of cerebral palsy. The American and
Canadian Pediatric societies and respected researchers have commented on the urgent need for
more trials of other corticosteroids at lower doses started after the first week of life to
evaluate their short and long-term pulmonary and neurological benefits and risks.
Research Design and Methods:
1. Inclusion & Exclusion Criteria: See below.
2. Procedures: Consented eligible patients will be randomly assigned to receive
hydrocortisone in a tapering schedule over 7 days or placebo (comparison group). Study
drug will be given every 12 hours IV with only study pharmacist aware of assignment.
The patient's anatomic brain MRI (routinely done on all ELBW infants at 38 weeks
post-menstrual age) will be further processed by the masked study investigators to
derive total and regional brain volumes. Administration of indomethacin or
dexamethasone to enrolled infants will be closely monitored and regulated throughout
the trial period. Indomethacin use during study period is contraindicated.
Dexamethasone (or other steroid) use will be restricted to ELBW infants on high
ventilator settings (RIS > 10) after 28 days of life. All other procedures will be per
routine care. Blinded developmental follow-up at two years, already currently performed
for all ELBW infants at MHCH, will be analyzed and reported for all study infants.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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