95
Participants
Start Date
January 2, 2024
Primary Completion Date
August 31, 2027
Study Completion Date
December 31, 2027
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"
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."
RECRUITING
Singapore General Hospital, Singapore
RECRUITING
KK Women's and Children Hospital, Singapore
Singapore General Hospital
OTHER
Genome Institute of Singapore
OTHER
Translational Immunology Institute
UNKNOWN
Duke-NUS Graduate Medical School
OTHER
KK Women's and Children's Hospital
OTHER_GOV