An interventional study of Glycerin Suppository and Sham Suppository in Feeding Intolerance in Premature Infants, sponsored by McMaster University. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2016-03-17.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 30 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note:
* C-reactive protein is not an exclusion criteria
** Indomethacin alone is not an exclusion criteria
Drug: Glycerin Suppository
Other: Sham Suppository
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.
Days 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
Recruitment rate
Percentage of eligible infants randomized
Time frame: 6 months
Completion rate
Percentage of randomized infants reaching full enteral feeds
Time frame: 6 months
Treatment-related adverse events
Rectal perforation, rectal bleeding, and/or anal fissure
Time frame: Up to 4 months
Cost
Time frame: 6 months
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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