COMPARISON OF ZINC AND PROBIOTICS ON NEONATES WITH INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY (ZIPP)

Quaid-e-Azam Medical College

Status and phase: Enrolling; Phase 2

Conditions: Neonatal; Indirect Hyperbilirubinemia

Treatments: Drug: Probiotic lactobacillus rhamnosus GG; Drug: Zinc sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT07102836

QAMC-CT-01

248/DME/QAMC Bahawalpur (Other Identifier)

Details and patient eligibility

About

Study will evaluate effects of oral zinc and probiotics supplementation in neonates who have indirect hyperbilirubinemia and are receiving phototherapy. Aim is to compare efficacy of these two drugs in clearing bilirubin and reducing duration of phototherapy. Neonates will be randomly assigned to receive either drug alongside phototherapy.

Enrollment: 110 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Term or Near term neonates 2. Age <7 days at enrollment 3. Bilirubin levels within phototherapy range according to NICE bilirubin threshold charts 4. No identifiable pathology 5. Tolerating oral feeds 6. Parental or Guardian written informed consent taken.

Exclusion criteria

• 1. Positive sepsis screen or clinical signs of infection 2. Direct hyperbilirubinemia 3. Gastrointestinal malformations 4. Oral intolerance 5. Requiring mechanical ventilation 6. Congenital anomalies 7. Parental or Guardian refusal to participate in study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Zinc group

Experimental group

Description:

Participants in this group will receive oral zinc following neonatal dosing guidelines.

Treatment:

Drug: Zinc sulfate

Probiotics group

Experimental group

Description:

Participants in this group will receive oral probiotics following neonatal dosing guidelines.

Treatment:

Drug: Probiotic lactobacillus rhamnosus GG