Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
Meconium Obstruction of Prematurity
About this trial
This is an interventional treatment trial for Meconium Obstruction of Prematurity
Eligibility Criteria
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 meconium obstruction at a later age (feed intolerance or vomiting and abnormal abdominal X-ray with or without abdominal distension) Exclusion Criteria: Infants that: Neuromuscular disorder Moderate or severe asphyxia Inability to start enteral feeding, which continued for 3 consecutive days before 2 weeks of post-natal age for reasons unrelated to meconium inspissation or its complication Without parental consent Aggravated medical instability Single mothers < 21 years
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention Arm (Saline Enema Arm)
Control Arm (Glycerin Suppository 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
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.