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.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 8 months
Healthy Volunteers: t
View:
• 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)
Locations
Other Locations
Singapore
KK Women's and Children Hospital
RECRUITING
Singapore
Singapore General Hospital
RECRUITING
Singapore
Contact Information
Primary
Seow Ching Li, Biomedical
li.seow.ching@kkh.com.sg
63948005
Backup
Kathy Liaw, Biomedical
kathy.liaw.c.s@singhealth.com.sg
63948939
Time Frame
Start Date:2024-01-02
Estimated Completion Date:2027-12-31
Participants
Target number of participants:95
Treatments
Experimental: Intervention Arm (Saline Enema Arm)
After randomisation, infant who allocated with intervention group will proceed with SE with normal saline (20-40ml/kg twice daily) earliest at 48 to 72 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
Active_comparator: Control Arm (Glycerin Suppository Arm)
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.