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Clinical Trials/CTRI/2025/04/084230
CTRI/2025/04/084230Not yet recruitingPhase 4

Effect of oral zinc supplementation in term neonates undergoing phototherapy for hyperbilirubinemia in an industrial hospital, a randomised control trial.

Tata Motors Hospital1 site in 1 country104 target enrollmentStarted: January 5, 2025Last updated:

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)

Investigators

Sponsor
Tata Motors Hospital
Sponsor Class
Private hospital/clinic

Study Sites (1)

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