Overview

Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.

Status:
RECRUITING

Trial end date:
2027-12-31

Target enrollment:

Participant gender:

Summary

The goal of this clinical trial is to study the effect of twice-daily saline enema (SE) in the treatment obstruction of prematurity (MOP) in infants with the birth weight ≤1.25kg. The main questions, the trial aims to answer are 1. To validate the finding of our pilot study which had shown that twice-daily SE reduces the time to reach full enteral feeds in premature infant as compared to premature infant treated with Glycerine Suppository (GS), in a larger cohort. Infant with MOP fails to pass meconium in the first 48 hours of life and develop symptoms and signs like abdominal distension and feed intolerance. 2. The other aims of this study are to test whether the intervention is 1. Effective treatment for MOP 2. Reduce the duration of ICU stay 3. Reduce the rate of necrotizing enterocolitis, sepsis, Total Parenteral Nutrition (TPN) days and number of intravenous catheter days 3. The study also wants to explore the impact of this intervention on the gut microbiome, gut-brain interaction and immune response of the new-born.

Phase:

Details

Lead Sponsor:

KK Women's and Children's Hospital

Collaborators:

Duke-NUS Graduate Medical School
Genome Institute of Singapore
Singapore General Hospital
Translational Immunology Institute