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Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial

NCT02153606 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-03-17

No results posted yet for this study

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.

Conditions

  • Feeding Intolerance in Premature Infants

Interventions

DRUG

Glycerin Suppository

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

OTHER

Sham Suppository

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.

Sponsors & Collaborators

  • McMaster Surgical Associates

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • J M Walton, M.D. · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-06-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02153606 on ClinicalTrials.gov