Indirect Hyperbilirubinemia, Neonatal
Conditions
Keywords
Zinc, Probiotics, Jaundice, Phototherapy, Neonates, Randomized Controlled Trial, Bilirubin, Enterohepatic Circulation, Indirect Hyperbilirubinemia
Brief summary
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.
Interventions
DRUGZinc sulfate
Oral zinc sulfate syrup in a dose providing 5mg elemental zinc daily as adjuvant to phototherapy.
DRUGProbiotic lactobacillus rhamnosus GG
Oral Probiotic Lactobacillus rhamnosus GG drops daily as adjuvant to phototherapy.
Sponsors
Quaid-e-Azam Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Both participants and care provider will be blinded to intervention allocation. Preparation of both drugs will be made identical in appearance and packaging to ensure unbiased administration and assessment during phototherapy.
Intervention model description
Participants will be randomly assigned to two groups. One group will receive Zinc and other will be receiving Probiotics. This will be done in continuation of Phototherapy to compare the effects of both drugs in reducing indirect hyperbilirubinemia.
Eligibility
Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of decline in Bilirubin levels during phototherapy with this adjuvant therapy | From initiation of supplementation with phototherapy to its completion (typically 3-7 days). | Primary outcome measures the rate at which total serum bilirubin decreases in mg/dL per day in neonates undergoing phototherapy while receiving supplementation with either zinc or probiotics. Bilirubin levels will be recorded at baseline and at regular intervals until phototherapy is discontinued and hence rate of decline will be calculated. |
Countries
Pakistan
Contacts
Primary ContactMalik M. Umair Fazal, MBBS, FCPS Paediatrics
Backup ContactDr. Muhammad Anwar, MBBS, FCPS Neonatology
Outcome results
None listed