Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.

Recruiting now · Not applicable

Conditions studied: Meconium Obstruction of Prematurity

In brief

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.

Key facts

Study ID

NCT06048614

Run by

KK Women's and Children's Hospital

People needed

95

Starts

2024-01-02

Expected to finish

2027-12-31

Last updated by the study team

2025-05-23

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Singapore General Hospital — Singapore, Singapore (enrolling)
• KK Women's and Children Hospital — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

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