Meconium evacuation trial in preterm infants

Not Applicable

Completed

• Conditions: Effect of aggressive meconium evacuation on establishment of oral feeds in very low birth weight infants (750-1500g); Surgery - Other surgery; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12614000128695
• Lead Sponsor: Dr Thowfique Ibrahim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Babies born in KK Hospital, Singapore with birth weight 750g-1.5kg meeting the following criteria:
1. No bowel output (BO) for 48 hours or
2. BO present but only meconium stain or
3. Bo present but small amount of meconium

Exclusion Criteria

1. Infants considered non viable by attending neonatologist.
2. Congenital malformation.
3. Infants with neuromuscular disorder.
4. Moderate or severe asphyxia.
5. Inability to start enteral feeding, which continued for more than 3 consecutive days before 2 weeks of postnatal age.
6. Aggravated medical disability.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary (efficacy) outcome is the median number of days from birth to reach full oral feeds of equal to or more than 110ml/kg/day.[Time when the infants reach full oral feeds (equal to or more than 110ml/kg/day)]

Secondary Outcome Measures

Name	Time	Method
Median number of neonatal intensive care unit (NICU) days[36 weeks of corrected age or time of discharge, whichever is earlier.];Median number of total parenteral nutrition (TPN) days[36 weeks of corrected age or time of discharge, whichever is earlier];Proportion of infants who have a positive culture sepsis[36 weeks of corrected age or time of discharge, whichever is earlier];Proportion of patients who develop necrotising enterocolitis (NEC)[36 weeks of corrected age or time of discharge, whichever is earlier];Proportion of patients who develop jaundice requiring phototherapy and among those who undergo phototherapy, median number of phototherapy days [36 weeks of corrected age or time of discharge, whichever is earlier];Treatment failure defined as the need for referral to surgeon and need for rectal washout GS arm; need for contrast enema; or need for laparotomy. [at 36 weeks corrected age or discharge whichever is earlier.]