Recruiting

Glycerin Suppositories

Sponsor:

McMaster University

Code:

NCT02153606

Conditions

Feeding Intolerance in Premature Infants

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Glycerin Suppository

Sham Suppository

Study Details

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.

Conditions

Feeding Intolerance in Premature Infants

Study ID

NCT02153606

Start date

Jan, 2015

Status verified date

Mar, 2016

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Glycerin Suppository

sham comparator: Sham Suppository

Interventions

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 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.

Primary outcome measure

  • Days to full enteral feeding (150 ml/kg/day) [ Time Frame: Up to 4 months ]

Central Contacts and Locations

Central contacts

Henrietta Blinder, BSc

905-521-2100blinderh@mcmaster.ca

Locations

McMaster University Medical Centre

Recruiting

Hamilton, Ontario, Canada, L8N3Z5

More Information

Sponsor

McMaster University

Last update posted

Mar 17, 2016

Last verified

Mar, 2016

Keywords

  • Glycerin Suppositories
  • Enteral Nutrition
  • Enterocolitis, Necrotizing
  • Infant, Premature
  • Meconium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2016-03-17.