Clinical Trial: Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Trial of Hydrocortisone in Very Preterm Infants at High Risk for Neurologic and Pulmonary Impairments

Brief 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.

Detailed Summary:

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
Sponsor: Nationwide Children's Hospital

Current Primary Outcome: Total Cerebral Volume as Measured by Volumetric Brain MRI [ Time Frame: 38 weeks postmenstrual age (PMA) ]

Total cerebral volume included all brain gray matter and white matter, including cerebellum.


Original Primary Outcome: Total cerebral volume as measured by volumetric brain MRI at 38 weeks post-menstrual age.

Current Secondary Outcome:

  • Regional Brain Volumes [ Time Frame: 38-weeks postmenstrual age ]
    Cerebral white matter volume
  • Duration of Positive Pressure Support (Mechanical Ventilation or Continuous Positive Airway Pressure) [ Time Frame: Up to 36 weeks PMA ]
  • Duration of Oxygen Requirement [ Time Frame: Up to 36 weeks PMA ]
  • Survival Without Severe Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 weeks postmenstrual age ]
    Using the NIH Consensus definition (Jobe A, 2001)


Original Secondary Outcome:

  • Neurosensory impairments at 18 to 22 months adjusted age
  • Regional Brain Volumes
  • Duration of mechanical ventilation
  • Duration of Oxygen Requirement
  • Diagnosis of BPD


Information By: Nationwide Children's Hospital

Dates:
Date Received: September 9, 2005
Date Started: November 2005
Date Completion:
Last Updated: July 29, 2013
Last Verified: July 2013