Using saline enemas to treat meconium obstruction in premature infants
Official title: The Administration of Saline Enema Versus Glycerin Suppository as a Treatment Intervention for Meconium Obstruction of Prematurity (MOP) and to Study the Impact on the Resolution of MOP, Time to Reach Full Enteral Feeds, Gut Microbiome, and Gut-brain Axis, a Randomised Control Trial.
Run by KK Women's and Children's Hospital · NCT06048614 · Data updated 2026-11-12
This study is testing if giving premature infants saline enemas can help them recover from meconium blockage faster than using glycerin suppositories.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 36 Weeks |
| Sex | All |
| Enrollment | 95 (estimated) |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 2 sites (Singapore and 1 other locations) |
| Status | Recruiting |
| Started | January 2, 2024 |
| Main results expected | August 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | May 23, 2025 |
| Trial ID | NCT06048614 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are premature infants with a birth weight of 500 to 1250 grams who show signs of meconium obstruction.
✕Probably not a fit
Patients with neuromuscular disorders, severe asphyxia, or other significant medical instabilities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of twice-daily saline enemas in treating meconium obstruction of prematurity in infants weighing 1.25 kg or less. The study aims to validate previous findings that saline enemas can reduce the time to reach full enteral feeds compared to glycerin suppositories. Additionally, it will assess the intervention's impact on ICU stay duration, rates of necrotizing enterocolitis, and the gut microbiome. Ninety-five infants will be enrolled and randomized to receive either saline enemas or glycerin suppositories.
Why it matters
Potential benefit: If successful, this treatment could significantly improve feeding outcomes and reduce complications in premature infants with meconium obstruction.
How similar studies have gone: Previous pilot studies have shown promising results for saline enemas in similar contexts, indicating potential for success in this larger trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Criteria A: For infant presenting with early onset of MOP 1. Birth weight 500 - 1250 gram 2. ≥ 23 weeks gestation 3. No BO for 48 hours 4. BO present but with a small amount or stain of meconium 5. Feeds intolerance or abdominal X-ray showing dilated loops of bowel * Criteria B: For infant presenting with Late onset of MOP 1. Birth weight 500 - 1250 gram 2. ≥ 23 weeks gestation 3. 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 Criteria: Infants that: 1. Neuromuscular disorder 2. Moderate or severe asphyxia 3. 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 4. Without parental consent 5. Aggravated medical instability 6. Single mothers \< 21 years
Where it's running
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Singapore General Hospital
Singapore, Singapore Recruiting -
KK Women's and Children Hospital
Singapore, Singapore Recruiting
Study contacts
- Principal investigator: Thowfique Ibrahim, FRCPCH, FAMS — Singhealth Duke-NUS Medical School, NUS and LKC Medical School
- Study coordinator: Seow Ching Li, Biomedical
- Email: li.seow.ching@kkh.com.sg
- Phone: 63948005
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.