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

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.

Study Overview

• Status: Unknown
• Conditions: Feeding Intolerance in Premature Infants
• Intervention / Treatment: Drug: Glycerin Suppository; Other: Sham Suppository

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henrietta Blinder, BSc; Phone Number: 73507 905-521-2100; Email: blinderh@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N3Z5
      • Recruiting
      • McMaster University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glycerin Suppository	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.
Sham Comparator: Sham Suppository	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Percentage of eligible infants randomized	6 months
Completion rate	Percentage of randomized infants reaching full enteral feeds	6 months
Treatment-related adverse events	Rectal perforation, rectal bleeding, and/or anal fissure	Up to 4 months
Cost		6 months

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation; McMaster Surgical Associates
• Investigators: Principal Investigator: J M Walton, M.D., McMaster University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: May 23, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Estimate): March 17, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Infant, Premature; Enteral Nutrition; Glycerin Suppositories; Enterocolitis, Necrotizing; Meconium
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: Walton-MSA14-GlycerinSupp