Meconium evacuation trial in preterm infants

The Effect of Early Aggressive Meconium Evacuation on Duration to Reach Full Oral Feeds in Very Low Birth Weight Infants: A Randomized Control Trial Comparing Regular Daily Saline Rectal Washout with Conventional Management using Glycerin Suppositories

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000128695

Acronym

MeVac Trial

Enrollment

Registered

2014-02-03

Start date

2013-11-26

Completion date

2015-10-07

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Meconium is the first stool all infants passes after birth. It is sticky and is black green colour. Infant's small and large guts are filled with meconium at birth. Meconium retention has become a recognized cause of bowel dysfunction in VLBW infants, causing delay in grading up of enteral feeds. Our goal is to shorten the duration to reach full oral feeds by aggressive meconium evacuation, thereby reducing the duration of NICU stay, incidence of necrotizing enterocolitis and sepsis, number of days an infant remains in total parental nutrition (TPN) and number of phototherapy days. Our primary hypothesis is that early evacuation of meconium with regular daily normal saline rectal washout (RW) in VLBW infants (750-1500g) with failed bowel opening for 48 hours reduces the duration to reach full feeds (equal to or more than 110ml/kg/day) as compared to conventional management with glycerin suppositories. 60 infants born over 18 months period from November 2013 in KK Hospital (KKH), Singapore will be enrolled. Infants are randomized at 48 hrs of age. Treatment group will receive RW at 48 hours of age and continued until 2 days of yellow stools or until infant reaches full feeds, whichever is earlier. Control group will follow conventional management protocol. Infants are followed up to 36 weeks of gestation or discharge whichever is earlier. Maternal and infant characteristics will be collected.

Interventions

Treatment group: Rectal washout with normal saline (10-20ml/kg for baby less than 1 kg, 20-40ml/kg for baby more than 1kg, twice a day) if infants failed to pass meconium at 48 hours of age, and rectal washout is continued until 1 day of yellow stools or equal to or more than 110ml/kg/day of feeds; whichever is earlier.

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

48 Hours to 4 Days

Healthy volunteers

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.

Outcome results