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

Primary Purpose

Feeding Intolerance in Premature Infants

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Glycerin Suppository
Sham Suppository
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding Intolerance in Premature Infants focused on measuring Glycerin Suppositories, Enteral Nutrition, Enterocolitis, Necrotizing, Infant, Premature, Meconium

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Glycerin Suppository

Sham Suppository

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Feeding volume on day 14 of life (ml/kg/day)
Days to complete meconium evacuation
Number of days to complete meconium evacuation (defined as two normal bowel movements free of meconium staining).
Compliance with treatment regimen
Days of parenteral nutrition
Necrotizing enterocolitis
Culture-proven line sepsis
Mortality

Full Information

First Posted
May 23, 2014
Last Updated
March 15, 2016
Sponsor
McMaster University
Collaborators
McMaster Surgical Associates, Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02153606
Brief Title
Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial
Official Title
Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
McMaster Surgical Associates, Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Intolerance in Premature Infants
Keywords
Glycerin Suppositories, Enteral Nutrition, Enterocolitis, Necrotizing, Infant, Premature, Meconium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glycerin Suppository
Arm Type
Active Comparator
Arm Title
Sham Suppository
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Glycerin Suppository
Intervention Description
The treatment intervention will be a 250 mg glycerin suppository placed in the rectum once daily starting 48-72 hours after birth.
Intervention Type
Other
Intervention Name(s)
Sham Suppository
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days to full enteral feeding (150 ml/kg/day)
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Feeding volume on day 14 of life (ml/kg/day)
Time Frame
14 days
Title
Days to complete meconium evacuation
Description
Number of days to complete meconium evacuation (defined as two normal bowel movements free of meconium staining).
Time Frame
Up to 4 months
Title
Compliance with treatment regimen
Time Frame
Up to 4 months
Title
Days of parenteral nutrition
Time Frame
Up to 4 months
Title
Necrotizing enterocolitis
Time Frame
Up to 4 months
Title
Culture-proven line sepsis
Time Frame
Up to 4 months
Title
Mortality
Time Frame
Up to 4 months
Other Pre-specified Outcome Measures:
Title
Recruitment rate
Description
Percentage of eligible infants randomized
Time Frame
6 months
Title
Completion rate
Description
Percentage of randomized infants reaching full enteral feeds
Time Frame
6 months
Title
Treatment-related adverse events
Description
Rectal perforation, rectal bleeding, and/or anal fissure
Time Frame
Up to 4 months
Title
Cost
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henrietta Blinder, BSc
Phone
905-521-2100
Ext
73507
Email
blinderh@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J M Walton, M.D.
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
27965809
Citation
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.
Results Reference
derived

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

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