Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial
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|ClinicalTrials.gov Identifier: NCT02153606|
Recruitment Status : Unknown
Verified March 2016 by McMaster University.
Recruitment status was: Recruiting
First Posted : June 3, 2014
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Feeding Intolerance in Premature Infants||Drug: Glycerin Suppository Other: Sham Suppository||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2016|
|Active Comparator: Glycerin Suppository||
Drug: 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 Comparator: Sham Suppository||
Other: 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.
- 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 [ Time Frame: Up to 4 months ]Number of days to complete meconium evacuation (defined as two normal bowel movements free of meconium staining).
- 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 [ Time Frame: 6 months ]Percentage of eligible infants randomized
- Completion rate [ Time Frame: 6 months ]Percentage of randomized infants reaching full enteral feeds
- Treatment-related adverse events [ Time Frame: Up to 4 months ]Rectal perforation, rectal bleeding, and/or anal fissure
- Cost [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153606
|Contact: Henrietta Blinder, BSc||905-521-2100 ext email@example.com|
|McMaster University Medical Centre||Recruiting|
|Hamilton, Ontario, Canada, L8N3Z5|
|Principal Investigator:||J M Walton, M.D.||McMaster University|