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

NARecruitingINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

January 2, 2024

Primary Completion Date

August 31, 2027

Study Completion Date

December 31, 2027

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."

Trial Locations (2)

169608

RECRUITING

Singapore General Hospital, Singapore

229899

RECRUITING

KK Women's and Children Hospital, Singapore

All Listed Sponsors
collaborator

Singapore General Hospital

OTHER

collaborator

Genome Institute of Singapore

OTHER

collaborator

Translational Immunology Institute

UNKNOWN

collaborator

Duke-NUS Graduate Medical School

OTHER

lead

KK Women's and Children's Hospital

OTHER_GOV