Actively Recruiting
Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
Led by KK Women's and Children's Hospital · Updated on 2025-05-23
95
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
K
KK Women's and Children's Hospital
Lead Sponsor
S
Singapore General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant birth weight between 500 and 1250 grams
- Gestational age of 23 weeks or more
- No bowel movement for 48 hours or presence of small amount or stain of meconium
- Feed intolerance or abdominal X-ray showing dilated bowel loops for early onset MOP
- Infants who passed meconium initially but develop symptoms of meconium obstruction later (feed intolerance, vomiting, abnormal abdominal X-ray with or without abdominal swelling)
You will not qualify if you...
- Diagnosed neuromuscular disorder
- Moderate or severe asphyxia
- Unable to start enteral feeding for 3 consecutive days before 2 weeks of age for reasons unrelated to meconium obstruction
- Lack of parental consent
- Medical instability worsened
- Single mothers younger than 21 years old
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Singapore General Hospital
Singapore, Singapore, 169608
Actively Recruiting
2
KK Women's and Children Hospital
Singapore, Singapore, 229899
Actively Recruiting
Research Team
S
Seow Ching Li, Biomedical
CONTACT
K
Kathy Liaw, Biomedical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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