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| Name | Class |
|---|---|
| McMaster Surgical Associates | OTHER |
| Hamilton Health Sciences Corporation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycerin Suppository | Active Comparator |
| |
| Sham Suppository | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycerin Suppository | Drug | The treatment intervention will be a 250 mg glycerin suppository placed in the rectum once daily starting 48-72 hours after birth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days to full enteral feeding (150 ml/kg/day) | Up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feeding volume on day 14 of life (ml/kg/day) | 14 days | |
| Days to complete meconium evacuation | Number of days to complete meconium evacuation (defined as two normal bowel movements free of meconium staining). |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Percentage of eligible infants randomized | 6 months |
| Completion rate | Percentage of randomized infants reaching full enteral feeds |
Inclusion Criteria:
Exclusion Criteria:
Note:
* C-reactive protein is not an exclusion criteria
** Indomethacin alone is not an exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henrietta Blinder, BSc | Contact | 905-521-2100 | 73507 | blinderh@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| J M Walton, M.D. | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University Medical Centre | Recruiting | Hamilton | Ontario | L8N3Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27965809 | Derived | 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. |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Sham Suppository | Other | 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. |
|
| Up to 4 months |
| Compliance with treatment regimen | Up to 4 months |
| Days of parenteral nutrition | Up to 4 months |
| Necrotizing enterocolitis | Up to 4 months |
| Culture-proven line sepsis | Up to 4 months |
| Mortality | Up to 4 months |
| 6 months |
| Treatment-related adverse events | Rectal perforation, rectal bleeding, and/or anal fissure | Up to 4 months |
| Cost | 6 months |
| D007410 |
| Intestinal Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |