Status:
COMPLETED
Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Neonatal Jaundice
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the effect of 10 mg of oral zinc given daily between days 2 and 7 of life to term or near term neonates with serum bilirubin levels of more than 6 mg/dL at 24...
Detailed Description
Neonatal hyperbilirubinemia is a common problem occurring in nearly 5-25% neonates.Inhibition of enterohepatic circulation is one of the therapies being tried for neonatal jaundice. Studies have sugge...
Eligibility Criteria
Inclusion
- Neonates born at ≥35 weeks gestation and with total serum bilirubin ≥ 6 mg/dL at 24±6 h of life.
Exclusion
- Rh incompatibility
- Those given exchange transfusion/ phototherapy within 24 h of age.
- Major gross congenital anomaly
- Anticipated to require neonatal intensive care or required neonatal intensive care for more than 24 h.
- Systemic sepsis
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT00692224
Start Date
October 1 2005
End Date
October 1 2006
Last Update
June 6 2008
Active Locations (1)
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1
All India Institute Of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029