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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
Sponsor:
Collaborators:
McMaster Surgical Associates
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Feeding Intolerance in Premature Infants Drug: Glycerin Suppository Other: Sham Suppository Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Glycerin

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Days to full enteral feeding (150 ml/kg/day) [ Time Frame: Up to 4 months ]

Secondary Outcome Measures :
  1. Feeding volume on day 14 of life (ml/kg/day) [ Time Frame: 14 days ]
  2. 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).

  3. Compliance with treatment regimen [ Time Frame: Up to 4 months ]
  4. Days of parenteral nutrition [ Time Frame: Up to 4 months ]
  5. Necrotizing enterocolitis [ Time Frame: Up to 4 months ]
  6. Culture-proven line sepsis [ Time Frame: Up to 4 months ]
  7. Mortality [ Time Frame: Up to 4 months ]

Other Outcome Measures:
  1. Recruitment rate [ Time Frame: 6 months ]
    Percentage of eligible infants randomized

  2. Completion rate [ Time Frame: 6 months ]
    Percentage of randomized infants reaching full enteral feeds

  3. Treatment-related adverse events [ Time Frame: Up to 4 months ]
    Rectal perforation, rectal bleeding, and/or anal fissure

  4. Cost [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Contacts
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Contact: Henrietta Blinder, BSc 905-521-2100 ext 73507 blinderh@mcmaster.ca

Locations
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Canada, Ontario
McMaster University Medical Centre Recruiting
Hamilton, Ontario, Canada, L8N3Z5
Sponsors and Collaborators
McMaster University
McMaster Surgical Associates
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: J M Walton, M.D. McMaster University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02153606     History of Changes
Other Study ID Numbers: Walton-MSA14-GlycerinSupp
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by McMaster University:
Glycerin Suppositories
Enteral Nutrition
Enterocolitis, Necrotizing
Infant, Premature
Meconium
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs