Effect of oral zinc supplementation in term neonates undergoing phototherapy for hyperbilirubinemia in an industrial hospital, a randomised control trial.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Rate of fall of total serum bilirubin levels.
Study Overview
Brief Summary
In this study, we will compare the effect of oral zinc supplementation in term neonates undergoing phototherapy for hyperbilirubinemia with others receiving only phototherapy in terms of rate of fall in serum bilirubin value and duration of phototherapy at TATA MOTORS HOSPITAL, JAMSHEDPUR.
I want to perform this study because the result will give a novel method of treatment for age old hyperbilirubinemia, reducing NICU stay and newborn and mother separation.
Approval of the instititional ethical committee was taken beforehand.
Written informed consent will be taken prior to the study. Caregivers and patients will be informed about the purpose of study and strict confidentiality will be ensured.
All the patients fitting into the inclusion criteria at NICU, Department of Paediatrics will be enrolled and proper history, examination and relevant investigations will be done.
Data collected wiil be analysed by preliminary data inspection, content analysis and interpretation.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 1.00 Day(s) to 28.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Term neonates with indirect hyperbilirubinemia under phototherapy range.
Exclusion Criteria
- •Preterm neonates.
- •Direct hyperbilirubinemia.
- •Systemic illness.
- •Severe sepsis.
- •Severe respiratory disease requiring mechanical ventilation Oral intolerance.
- •Major gross congenital anomalies (GI malformations, heart and neural tube defects etc).
- •Term neonates with hyperbilirubinemia in exchange transfusion range.
Outcomes
Primary Outcomes
Rate of fall of total serum bilirubin levels.
Time Frame: 3 DAYS
Secondary Outcomes
- Duration of phototherapy.(3 DAYS)