Status:
RECRUITING
Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
Lead Sponsor:
KK Women's and Children's Hospital
Collaborating Sponsors:
Singapore General Hospital
Genome Institute of Singapore
Conditions:
Meconium Obstruction of Prematurity
Eligibility:
All Genders
1-36 years
Phase:
NA
Brief 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, ...
Detailed Description
Very low birth weight infants (VLBW ≤ 1.5 kg) constitute more than 60% of bed occupancy in level III neonatal units. They face the risk of 10-50% long-term disability, and their initial healthcare cos...
Eligibility Criteria
Inclusion
- Criteria A: For infant presenting with early onset of MOP
- Birth weight 500 - 1250 gram
- ≥ 23 weeks gestation
- No BO for 48 hours
- BO present but with a small amount or stain of meconium
- Feeds intolerance or abdominal X-ray showing dilated loops of bowel
- Criteria B: For infant presenting with Late onset of MOP
- Birth weight 500 - 1250 gram
- ≥ 23 weeks gestation
- Infants who passed meconium initially and develop evidence of meconium obstruction at a later age (feed intolerance or vomiting and abnormal abdominal X-ray with or without abdominal distension)
Exclusion
- Infants that:
- Neuromuscular disorder
- Moderate or severe asphyxia
- Inability to start enteral feeding, which continued for 3 consecutive days before 2 weeks of post-natal age for reasons unrelated to meconium inspissation or its complication
- Without parental consent
- Aggravated medical instability
- Single mothers \< 21 years
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT06048614
Start Date
January 2 2024
End Date
December 31 2027
Last Update
May 23 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Singapore General Hospital
Singapore, Singapore, 169608
2
KK Women's and Children Hospital
Singapore, Singapore, 229899