Premature Birth Clinical Trial
Official title:
A Randomized Trial of Hydrocortisone in Very Preterm Infants at High Risk for Neurologic and Pulmonary Impairments
Verified date | July 2013 |
Source | Nationwide Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | November 2012 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 3 Weeks |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Nationwide Children's Hospital | National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH) |
United States,
Parikh NA, Kennedy KA, Lasky RE, McDavid GE, Tyson JE. Pilot randomized trial of hydrocortisone in ventilator-dependent extremely preterm infants: effects on regional brain volumes. J Pediatr. 2013 Apr;162(4):685-690.e1. doi: 10.1016/j.jpeds.2012.09.054. — View Citation
Parikh NA, Lasky RE, Kennedy KA, Moya FR, Hochhauser L, Romo S, Tyson JE. Postnatal dexamethasone therapy and cerebral tissue volumes in extremely low birth weight infants. Pediatrics. 2007 Feb;119(2):265-72. — View Citation
Yu X, Zhang Y, Lasky RE, Datta S, Parikh NA, Narayana PA. Comprehensive brain MRI segmentation in high risk preterm newborns. PLoS One. 2010 Nov 8;5(11):e13874. doi: 10.1371/journal.pone.0013874. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Cerebral Volume as Measured by Volumetric Brain MRI | Total cerebral volume included all brain gray matter and white matter, including cerebellum. | 38 weeks postmenstrual age (PMA) | Yes |
Secondary | Regional Brain Volumes | Cerebral white matter volume | 38-weeks postmenstrual age | Yes |
Secondary | Duration of Positive Pressure Support (Mechanical Ventilation or Continuous Positive Airway Pressure) | Up to 36 weeks PMA | No | |
Secondary | Duration of Oxygen Requirement | Up to 36 weeks PMA | No | |
Secondary | Survival Without Severe Bronchopulmonary Dysplasia (BPD) | Using the NIH Consensus definition (Jobe A, 2001) | 36 weeks postmenstrual age | No |
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