Status:

RECRUITING

Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice

Lead Sponsor:

Chinese University of Hong Kong

Conditions:

Neonatal Jaundice

Microtia

Eligibility:

FEMALE

18-45 years

Phase:

PHASE2

Brief Summary

This is a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group) to investigate the effect of maternal perinatal probiotic supp...

Detailed Description

Neonatal jaundice is a yellowish discoloration of the skin and sclera because of over-concentration of circulating unconjugated bilirubin (hyperbilirubinemia) in the body. It can lead the baby to seve...

Eligibility Criteria

Inclusion

  • All pregnant women aged 18-45 years old.
  • Gestational age of 28-34 weeks
  • Normal singleton pregnancy

Exclusion

  • Foetal abnormality
  • Mothers with antibiotic medication during the allocation
  • Couples with glucose 6-phosphate dehydrogenase enzyme deficiency
  • Couples with known rhesus or haemolytic disease history
  • Plan of place of birth at other hospitals other than Prince of Wales Hospital
  • known breast disorder or any contraindication for breastfeeding.

Key Trial Info

Start Date :

March 23 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2025

Estimated Enrollment :

94 Patients enrolled

Trial Details

Trial ID

NCT06087874

Start Date

March 23 2024

End Date

June 1 2025

Last Update

May 20 2024

Active Locations (1)

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1

Prince of Wales Hospital

Hong Kong, New Territories, Hong Kong, 0852