Clinical trial NCT02153606: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Feeding Intolerance in Premature Infants
Keywords: Glycerin Suppositories
Enteral Nutrition
Enterocolitis, Necrotizing
Infant, Premature
Meconium
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster Surgical Associates
name: Hamilton Health Sciences Corporation
First posted: 2014-06-03
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Days to full enteral feeding (150 ml/kg/day)
timeFrame: Up to 4 months
Secondary outcomes:
measure: Feeding volume on day 14 of life (ml/kg/day)
timeFrame: 14 days
measure: Days to complete meconium evacuation
timeFrame: Up to 4 months
measure: Compliance with treatment regimen
timeFrame: Up to 4 months
measure: Days of parenteral nutrition
timeFrame: Up to 4 months
measure: Necrotizing enterocolitis
timeFrame: Up to 4 months
measure: Culture-proven line sepsis
timeFrame: Up to 4 months
measure: Mortality
timeFrame: Up to 4 months
Other outcomes:
measure: Recruitment rate
timeFrame: 6 months
measure: Completion rate
timeFrame: 6 months
measure: Treatment-related adverse events
timeFrame: Up to 4 months
measure: Cost
timeFrame: 6 months
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: J M Walton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.