NCT06048614 Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
| NCT ID | NCT06048614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KK Women's and Children's Hospital |
| Condition | Meconium Obstruction of Prematurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 95 participants in total. It began in 2024-01-02 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
Eligibility 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
Contact & Investigator
Thowfique Ibrahim, FRCPCH, FAMS
PRINCIPAL INVESTIGATOR
Singhealth Duke-NUS Medical School, NUS and LKC Medical School
Frequently Asked Questions
Who can join the NCT06048614 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 36 Weeks, studying Meconium Obstruction of Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06048614 currently recruiting?
Yes, NCT06048614 is actively recruiting participants. Contact the research team at li.seow.ching@kkh.com.sg for enrollment information.
Where is the NCT06048614 trial being conducted?
This trial is being conducted at Singapore, Singapore, Singapore, Singapore.
Who is sponsoring the NCT06048614 clinical trial?
NCT06048614 is sponsored by KK Women's and Children's Hospital. The principal investigator is Thowfique Ibrahim, FRCPCH, FAMS at Singhealth Duke-NUS Medical School, NUS and LKC Medical School. The trial plans to enroll 95 participants.