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

Phase

N/A

Condition

Ileus

Cystic Fibrosis

Constipation

Treatment

Glycerin Suppository

Saline Enema (SE)

Clinical Study ID

NCT06048614

2023/2270

Ages 1-36
All Genders
Accepts Healthy Volunteers

Study 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

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.
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
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

Inclusion Criteria:

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 meconiumobstruction at a later age (feed intolerance or vomiting and abnormal abdominalX-ray with or without abdominal distension)

Exclusion

Exclusion Criteria:

Infants that:

Neuromuscular disorder
Moderate or severe asphyxia
Inability to start enteral feeding, which continued for 3 consecutive days before 2weeks of post-natal age for reasons unrelated to meconium inspissation or itscomplication
Without parental consent
Aggravated medical instability
Single mothers < 21 years

Study Design

Glycerin Suppository

January 02, 2024

December 31, 2027

Study Description

Very low birth weight infants (VLBW ≤ 1.5 kg) constitute more than 60% of bed occupancy in level III neonatal units. They face the risk of 10-50% long-term disability, and their initial healthcare cost ranges from S$50,000 to 1 million, an important healthcare issue.

The incidence of meconium obstruction of prematurity (MOP) is 20-30% in extremely low birth weight (ELBW ≤ 1 kg) infants. The intervention based on the current standard of care increase the risk of laparotomy necrotizing enterocolitis, intestinal perforation, and neurodevelopmental risks posed by general anaesthesia. Our published pilot RCT demonstrated that saline enema (SE) is an effective, feasible, and safe intervention to reduce the time to reach full enteral feeds and is a potentially effective treatment for MOP in ELBW (< 1 kg) infants.

Our primary hypothesis is that Infants with Twice-daily high-volume SE (20-40 ml/kg/day) intervention will result in reduced time to reach full enteral feeds compared to infants treated with conventional management with Glycerin suppository (GS) in (≤1.25kg) infants with MOP. Our exploratory hypothesis is that SE will have a protective effect on the gut microbiome, inflammatory and immune response in preterm infants.

Ninety-five infants born over three years in KK Hospital (KKH) and Singapore General Hospital (SGH) will be enrolled and randomized at 48 hours or later to receive SE or GS. The standardized protocol will be used for the accreditation and administration of SE. Primary, secondary, and exploratory outcomes data, including treatment failure data, will be recorded. Infants will be followed up to 36 weeks of gestation or discharge, whichever is earlier. Maternal and infant characteristics, inflammatory and immune response, and safety outcome data will be collected.

If the findings of our pilot trial are confirmed, the protocol can become the standard of care in preterm infants with MOP. Additionally, significant healthcare cost savings will be realized alongside an improved understanding of the Microbiome, immune and inflammatory response pertaining to the gut.

Connect with a study center

KK Women's and Children Hospital
Singapore, 229899
Singapore
Active - Recruiting
Singapore General Hospital
Singapore, 169608
Singapore
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.