NCT02153606

Brief Summary

All premature babies have problems with feeding and nutrition. Some can develop a life-threatening bowel infection necrotizing enterocolitis. This can result in the need for emergency surgery, loss of bowel, lifelong feeding problems, and death. Giving premature babies glycerin suppositories may be one way to stimulate the digestive tract and help prevent these problems. To see if this treatment works, the investigators need to study hundreds of premature babies in a large trial involving multiple hospitals. The purpose of this project is to carry out a small study first and make sure that the larger trial is feasible. The investigators will invite approximately 30 premature babies from the Neonatal Intensive Care Unit at McMaster University Medical Centre to participate in this study over a 6-month period. The investigators will focus on feasibility issues, including cost, safety, and rate of participation. This will allow us to rigorously test our study protocol and lay the groundwork for the larger study involving multiple hospitals.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

1.4 years

First QC Date

May 23, 2014

Last Update Submit

March 15, 2016

Conditions

Feeding Intolerance in Premature Infants

Keywords

Glycerin SuppositoriesEnteral NutritionEnterocolitis, NecrotizingInfant, PrematureMeconium

Outcome Measures

Primary Outcomes (1)

  • Days to full enteral feeding (150 ml/kg/day)

    Up to 4 months

Secondary Outcomes (7)

  • Feeding volume on day 14 of life (ml/kg/day)

    14 days

  • Days to complete meconium evacuation

    Up to 4 months

  • Compliance with treatment regimen

    Up to 4 months

  • Days of parenteral nutrition

    Up to 4 months

  • Necrotizing enterocolitis

    Up to 4 months

  • +2 more secondary outcomes

Other Outcomes (4)

  • Recruitment rate

    6 months

  • Completion rate

    6 months

  • Treatment-related adverse events

    Up to 4 months

  • +1 more other outcomes

Study Arms (2)

Glycerin Suppository

ACTIVE COMPARATOR
Drug: Glycerin Suppository

Sham Suppository

SHAM COMPARATOR
Other: Sham Suppository

Interventions

Glycerin SuppositoryDRUG

The treatment intervention will be a 250 mg glycerin suppository placed in the rectum once daily starting 48-72 hours after birth.

Glycerin Suppository
Sham SuppositoryOTHER

Sham suppositories will be created by placing a 250 mg glycerin suppository in the diaper once daily starting 48-72 hours after birth. This intervention works as a non-invasive placebo to maintain blinding.

Sham Suppository

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age 24-32 weeks OR
  • Birth weight 500-1500 grams

You may not qualify if:

  • Congenital gastrointestinal anomalies
  • Surgery within 48 hours of birth
  • Culture-proven sepsis\*
  • Vasopressors within 6 hours of first intervention
  • Nitric oxide
  • Duct-dependent congenital heart defect requiring prostaglandins
  • Suspected coagulopathy (mucosal bleeding from any orifice)
  • Confirmed coagulopathy (any one of the following):
  • International Normalized Ratio greater than 1.4
  • Partial Thromboplastin Time greater than 39 seconds
  • Fibrinogen less than 1.00 grams/liter
  • Thrombocytopenia (platelet count less than 100 x 10\^9/liter)\*\*
  • Neutropenia (absolute neutrophil count less than 0.5 x 10\^9/liter)
  • Complete meconium evacuation (2 normal bowel movements) within 48 hours of life
  • Parent or legal guardian unable to understand English
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8N3Z5, Canada

RECRUITING

Related Publications (1)

  • Livingston MH, Zequeira J, Blinder H, Pemberton J, Williams C, Walton JM. Glycerin suppositories used prophylactically in premature infants (SUPP) trial: a study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2015 Aug 25;1:31. doi: 10.1186/s40814-015-0024-0. eCollection 2015.

    PMID: 27965809DERIVED

MeSH Terms

Conditions

Enterocolitis, NecrotizingPremature Birth

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • J M Walton, M.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrietta Blinder, BSc

CONTACT

905-521-2100blinderh@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

June 3, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

CA(1)