Neonatal Jaundice Clinical Trial
Official title:
Effect 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 ± 6 Hours of Life on Hyperbilirubinemia and Phototherapy
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 ± 6 hours of life on hyperbilirubinemia and phototherapy.
Status | Completed |
Enrollment | 294 |
Est. completion date | October 2006 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 30 Hours |
Eligibility |
Inclusion Criteria: - Neonates born at =35 weeks gestation and with total serum bilirubin = 6 mg/dL at 24±6 h of life. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
India | All India Institute Of Medical Sciences | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of hyperbilirubinemia defined as total serum bilirubin more than or equal to 15 mg/dL at anytime between days 2 and 7 of life. | first week of life | Yes | |
Secondary | The mean total serum bilirubin level at 72±12 hours of age. | first two weeks of life | Yes | |
Secondary | The proportion of infants requiring phototherapy and the duration thereof | first two weeks of life | Yes |
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