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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Feeding Intolerance in Premature Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glycerin Suppository

Group Type ACTIVE_COMPARATOR

Glycerin Suppository

Intervention Type DRUG

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

Sham Suppository

Group Type SHAM_COMPARATOR

Sham Suppository

Intervention Type OTHER

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.

Interventions

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Glycerin Suppository

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

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Note:

Eligible Sex

ALL

Accepts Healthy Volunteers

No