Using saline enemas to treat meconium obstruction in premature infants
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.
This study is testing if giving premature infants saline enemas can help them recover from meconium blockage faster than using glycerin suppositories.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 1 Day to 36 Weeks |
| Sex | All |
| Sponsor | KK Women's and Children's Hospital Government |
| Locations | 2 sites (Singapore and 1 other locations) |
| Trial ID | NCT06048614 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are premature infants with a birth weight of 500 to 1250 grams who show signs of meconium obstruction.
Not a fit: Patients with neuromuscular disorders, severe asphyxia, or other significant medical instabilities may not benefit from this study.
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 performed: Previous pilot studies have shown promising results for saline enemas in similar contexts, indicating potential for success in this larger trial.
Eligibility criteria
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 this trial is running
Singapore and 1 other locations
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.