Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000128695
Ethics application status
Approved
Date submitted
22/01/2014
Date registered
3/02/2014
Date last updated
12/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Meconium evacuation trial in preterm infants
Scientific title
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
Secondary ID [1] 283949 0
None
Universal Trial Number (UTN)
U1111-1152-4086
Trial acronym
MeVac Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of aggressive meconium evacuation on establishment of oral feeds in very low birth weight infants (750-1500g) 290974 0
Condition category
Condition code
Surgery 291317 291317 0 0
Other surgery
Reproductive Health and Childbirth 291388 291388 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288639 0
Treatment: Surgery
Comparator / control treatment
Infants are administered gylcerine suppository (1/4) if baby failed to pass meconium in 48 hours. If meconium is passed, feeds are tolerated, suppositories will be discontinued. If problems persist, i.e. feed intolerance/ abdominal distention, babies are referred to paediatric surgeon who will initiate rectal washout.
Control group
Active

Outcomes
Primary outcome [1] 291310 0
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.
Timepoint [1] 291310 0
Time when the infants reach full oral feeds (equal to or more than 110ml/kg/day)
Secondary outcome [1] 306484 0
Median number of neonatal intensive care unit (NICU) days
Timepoint [1] 306484 0
36 weeks of corrected age or time of discharge, whichever is earlier.
Secondary outcome [2] 306633 0
Median number of total parenteral nutrition (TPN) days
Timepoint [2] 306633 0
36 weeks of corrected age or time of discharge, whichever is earlier
Secondary outcome [3] 306634 0
Proportion of infants who have a positive culture sepsis
Timepoint [3] 306634 0
36 weeks of corrected age or time of discharge, whichever is earlier
Secondary outcome [4] 306635 0
Proportion of patients who develop necrotising enterocolitis (NEC)
Timepoint [4] 306635 0
36 weeks of corrected age or time of discharge, whichever is earlier
Secondary outcome [5] 306636 0
Proportion of patients who develop jaundice requiring phototherapy and among those who undergo phototherapy, median number of phototherapy days
Timepoint [5] 306636 0
36 weeks of corrected age or time of discharge, whichever is earlier
Secondary outcome [6] 322803 0
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.
Timepoint [6] 322803 0
at 36 weeks corrected age or discharge whichever is earlier.

Eligibility
Key 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
Minimum age
48 Hours
Maximum age
4 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following consent from parents and treatment team, infants are allocated to the study arms by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Interventional arm receive only rectal washout. However, the conventional management can receive rectal washout if glycerine suppository fails. Both arms can receive contrast enema and laparotomy according to surgeon discretion if rectal washout in study arm or glycerin suppository+ rectal washout in conventional arm fails.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The effect of early aggressive meconium evacuation with rectal washout versus conventional management with glycerin suppository will be evaluated using survival analysis. The Cox Propertional Hazards (PH) model will be used to assess the treatment effect, expressed as a hazard ratio (with 95% confidence interval) adjusted for the effect of birth weight (<1kg versus 1-1.5kg) and other prognostic factors, as necessary. Covariate-dependent confidence intervals for the difference between median during times under a stratified Cox PH model will be derived using the method of Chen and Chang (2007). The Kaplan-Meier technique will be used to derive cumulative incidence rates at the end of the study and construct plots.

Sample size: To detect a difference of in the median duration to full oral feeds of equal to or more than 110mlkg/day in a two sided test at alpha=0.05 and 1-0.80, assuming that the median duration under control is M1 days, and under treatment is M2 days, a sample of size n is required. Final study size will depend on pilot study estimates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/11/2013
Actual
26/11/2013
Date of last participant enrolment
Anticipated
30/06/2015
Actual
7/10/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
61
Recruitment outside Australia
Country [1] 5770 0
Singapore
State/province [1] 5770 0

Funding & Sponsors
Funding source category [1] 288596 0
University
Name [1] 288596 0
Duke NUS Khoo Foundation
Country [1] 288596 0
Singapore
Primary sponsor type
Individual
Name
Dr Thowfique Ibrahim
Address
Dept of Neonatology
KK Women's and Children's Hospital
100 Bukit Timah Road
Singapore 229899
Country
Singapore
Secondary sponsor category [1] 287307 0
None
Name [1] 287307 0
Address [1] 287307 0
Country [1] 287307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290460 0
Centralised Institutional Review Board (CIRB)
Ethics committee address [1] 290460 0
Office of Research
Singapore Health Services Pte Ltd
7 Hospital Drive,
#03-01, Block A
Singhealth Research Facilities
Singapore 169611
Ethics committee country [1] 290460 0
Singapore
Date submitted for ethics approval [1] 290460 0
29/05/2013
Approval date [1] 290460 0
12/08/2013
Ethics approval number [1] 290460 0
2013/441/E

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45742 0
Dr Thowfique Ibrahim
Address 45742 0
A/Asst Professor,
National University of Singapore,
Duke NUS Graduate Medical School.

Consultant,
Dept. of Neonatology,
KK Women's and Children's Hospital,
100 Bukit Timah Road, Singapore 229899.
Country 45742 0
Singapore
Phone 45742 0
+6563941836
Fax 45742 0
Email 45742 0
Thowfique.Ibrahim@kkh.com.sg
Contact person for public queries
Name 45743 0
Dr Thowfique Ibrahim
Address 45743 0
A/Asst Professor,
National University of Singapore,
Duke NUS Graduate Medical School.

Consultant,
Dept. of Neonatology,
KK Women's and Children's Hospital,
100 Bukit Timah Road, Singapore 229899.
Country 45743 0
Singapore
Phone 45743 0
+6563941836
Fax 45743 0
Email 45743 0
Thowfique.Ibrahim@kkh.com.sg
Contact person for scientific queries
Name 45744 0
Dr Thowfique Ibrahim
Address 45744 0
A/Asst Professor,
National University of Singapore,
Duke NUS Graduate Medical School.

Consultant,
Dept. of Neonatology,
KK Women's and Children's Hospital,
100 Bukit Timah Road, Singapore 229899.
Country 45744 0
Singapore
Phone 45744 0
+6563941836
Fax 45744 0
Email 45744 0
Thowfique.Ibrahim@kkh.com.sg

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSaline Enemas versus Glycerin Suppositories to Promote Enteral Feeding in Premature Infants: A Pilot Randomized Controlled Trial.2017https://dx.doi.org/10.1159/000477999
N.B. These documents automatically identified may not have been verified by the study sponsor.