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

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.

Conditions

• Meconium Obstruction of Prematurity

Interventions

PROCEDURE

Saline Enema (SE)

infant who allocated with intervention group will proceed with SE with normal saline (20-40ml/kg twice daily) at 48 hours of age. Then continue until 2 days of yellow stools/ 110ml/kg/day of oral feeds; whichever is earlier. SE are recommended if baby do not do bowel opening (BO) for 2 days before reaching full feeds Failure to resolve the MOP with SE will be designated as treatment failure and managed with contrast enema or Laparotomy by paediatric surgeons, following a formal referral.GS is not allowed in intervention arm

DRUG

Glycerin Suppository

Infants randomized to GS received the standard management protocol for meconium retention in the unit. GS (2,000 mg, a quarter unit, four doses 12 h apart) were administered to infants earliest at 48 hour to 72 hours of birth, with subsequent once-daily GS being administered at the discretion of the managing team. Infants who were diagnosed with meconium obstruction later in the first 2 weeks of life were also treated with glycerin suppositories for 48 hrs, with subsequent once-daily GS being administered at the discretion of the managing team. Infants who failed to respond to glycerin suppositories were referred to the surgical team by the managing team The subsequent management of meconium retention was at the surgeon's discretion and included continued GS by the surgical team, contrast enema or surgical interventions performed in escalating order as mentioned.

Sponsors & Collaborators

• Singapore General Hospital

  collaborator OTHER

• Genome Institute of Singapore

  collaborator OTHER

• Translational Immunology Institute

  collaborator UNKNOWN

• Duke-NUS Graduate Medical School

  collaborator OTHER

• KK Women's and Children's Hospital

  lead OTHER_GOV

Principal Investigators

• Thowfique Ibrahim, FRCPCH, FAMS · Singhealth Duke-NUS Medical School, NUS and LKC Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

36 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-02

Primary Completion

2027-08-31

Completion

2027-12-31

Countries

• Singapore

Study Locations