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

Study Overview
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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.

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

Conditions
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Feeding Intolerance in Premature Infants

Intervention / Treatment
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* Drug: Glycerin Suppository
* Other: Sham Suppository


Participation Criteria
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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: * C-reactive protein is not an exclusion criteria ** Indomethacin alone is not an exclusion criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glycerin Suppository<br> | Drug: Glycerin Suppository<br>* The treatment intervention will be a 250 mg glycerin suppository placed in the rectum once daily starting 48-72 hours after birth.<br>|
| Sham Comparator: Sham Suppository<br> | Other: Sham Suppository<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to full enteral feeding (150 ml/kg/day) |  | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding volume on day 14 of life (ml/kg/day) |  | 14 days | 
| Days to complete meconium evacuation | Number of days to complete meconium evacuation (defined as two normal bowel movements free of meconium staining). | 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 | 
| Culture-proven line sepsis |  | Up to 4 months | 
| Mortality |  | Up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycerin Suppositories, Enteral Nutrition, Enterocolitis, Necrotizing, Infant, Premature, Meconium