Status:
COMPLETED
Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
BC Research Inc.
Conditions:
Neonatal Hypotension
Eligibility:
All Genders
48-30 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the early use of hydrocortisone in hypotensive very low birth weight infants. Based on the observations that: * hypotension is a common problem in very lo...
Detailed Description
Eligible infants will be randomly assigned to receive hydrocortisone or placebo, using sequentially numbered, preassigned treatment designations in sealed, opaque envelopes. The study drug will be ran...
Eligibility Criteria
Inclusion
- Gestational age ≤ 30 weeks, Birth weight ≤ 1250 grams and ≤ 48 hours age;
- Umbilical or peripheral arterial catheter in place;
- Invasive mean blood pressure \< gestational age in completed weeks after 1 Normal Saline bolus 10 ml/kg;
- Parental/legal guardian consent.
Exclusion
- Clear evidence of hypovolemia (blood loss);
- Chromosomal abnormalities;
- Hydrops fetalis;
- Major congenital anomalies;
- Cardiac lesions other than patent ductus arteriosus.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00358748
Start Date
July 1 2005
End Date
May 1 2010
Last Update
April 12 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Division of Neonatology, Children's and Women's Health Centre
Vancouver, British Columbia, Canada