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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
The treatment intervention will be a 250 mg glycerin suppository placed in the rectum once daily starting 48-72 hours after birth.
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.
McMaster University Medical Centre
Hamilton, Ontario, Canada
RECRUITINGDays to full enteral feeding (150 ml/kg/day)
Time frame: Up to 4 months
Feeding volume on day 14 of life (ml/kg/day)
Time frame: 14 days
Days to complete meconium evacuation
Number of days to complete meconium evacuation (defined as two normal bowel movements free of meconium staining).
Time frame: Up to 4 months
Compliance with treatment regimen
Time frame: Up to 4 months
Days of parenteral nutrition
Time frame: Up to 4 months
Necrotizing enterocolitis
Time frame: Up to 4 months
Culture-proven line sepsis
Time frame: Up to 4 months
Mortality
Time frame: Up to 4 months
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