Feeding Intolerance in Premature InfantsNCT02153606
Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial
A study testing Glycerin Suppository in people with Feeding Intolerance in Premature Infants, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Feeding Intolerance in Premature Infants
- What is being tested?
- Glycerin Suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age 24-32 weeks OR
- Birth weight 500-1500 grams
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster University Medical Centre
Hamilton, Ontario, L8N3Z5
About this study
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.
- Conditions
- Feeding Intolerance in Premature Infants
- Being tested
- Glycerin Suppository, Sham Suppository
- Keywords
- Glycerin Suppositories, Enteral Nutrition, Enterocolitis, Necrotizing, Infant, Premature, Meconium
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycerin SuppositoryDrug
The treatment intervention will be a 250 mg glycerin suppository placed in the rectum once daily starting 48-72 hours after birth.
Sham SuppositoryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Glycerin Suppository | Active comparator | Not described Receives: Drug: Glycerin Suppository |
| Sham Suppository | Sham comparator | Not described Receives: Other: Sham Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to full enteral feeding (150 ml/kg/day)
Measured: Up to 4 months
Secondary outcomes (7)
Feeding volume on day 14 of life (ml/kg/day)
Measured: 14 days
Days to complete meconium evacuation
Number of days to complete meconium evacuation (defined as two normal bowel movements free of meconium staining).
Measured: Up to 4 months
Compliance with treatment regimen
Measured: Up to 4 months
Days of parenteral nutrition
Measured: Up to 4 months
Necrotizing enterocolitis
Measured: Up to 4 months
Culture-proven line sepsis
Measured: Up to 4 months
Mortality
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding Intolerance in Premature InfantsStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Surgical Associates, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- J M Walton, M.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153606
- Sponsor's protocol ID
- Walton-MSA14-GlycerinSupp
- Status last verified
- Mar 2016
- First submitted
- 23 May 2014
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27965809
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02153606
- Acronym / sponsor ID
- Walton-MSA14-GlycerinSupp
- Conditions
- Feeding Intolerance in Premature Infants
- Keywords
- Glycerin Suppositories, Enteral Nutrition, Enterocolitis, Necrotizing, Infant, Premature, Meconium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- McMaster Surgical Associates, Hamilton Health Sciences Corporation
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycerin Suppository | Active comparator | Drug: Glycerin Suppository |
| Sham Suppository | Sham comparator | Other: Sham Suppository |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Gestational age 24-32 weeks OR
- Birth weight 500-1500 grams
Key exclusion criteria (18 listed)
- Congenital gastrointestinal anomalies
- Surgery within 48 hours of birth
- Culture-proven sepsis*
- Vasopressors within 6 hours of first intervention
- Nitric oxide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycerin SuppositoryThe treatment intervention will be a 250 mg glycerin suppository placed in the rectum once daily starting 48-72 hours after birth. | Drug | Glycerin Suppository |
| Sham SuppositorySham 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. | Other | Sham Suppository |
Primary outcome
Days to full enteral feeding (150 ml/kg/day)
Time frame: Up to 4 months
7 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Derived from this study: PubMed 27965809Livingston 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J M Walton, M.D. principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycerin Suppository in people with Feeding Intolerance in Premature Infants, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henrietta Blinder, BSc (905-521-2100 ext. 73507, blinderh@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days to full enteral feeding (150 ml/kg/day) (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02153606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.