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Glycerin Suppositories for Premature Infants

N/A

Waitlist Available

Led By J M Walton, M.D.

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gestational age 24-32 weeks OR Birth weight 500-1500 grams

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing whether glycerin suppositories may help prevent a life-threatening bowel infection in premature babies.

Who is the study for?

This trial is for premature infants born between 24-32 weeks of gestation or those with a birth weight of 500-1500 grams. It aims to help prevent feeding and digestive problems, including a serious bowel infection called necrotizing enterocolitis.Check my eligibility

What is being tested?

The study is testing if glycerin suppositories can stimulate the digestive system in premature babies to prevent complications. Babies will be randomly given either a real glycerin suppository or a sham (fake) one as part of the pilot study at McMaster University Medical Centre.See study design

What are the potential side effects?

Potential side effects may include mild discomfort or irritation where the suppository is inserted. Since this is a preliminary study, part of its purpose is to assess safety and any other possible side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Days to full enteral feeding (150 ml/kg/day)

Secondary outcome measures

Compliance with treatment regimen

Culture-proven line sepsis

Days of parenteral nutrition

+4 more

Other outcome measures

Completion rate

Cost

Recruitment rate

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Glycerin SuppositoryActive Control1 Intervention

Group II: Sham SuppositoryPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

881 Previous Clinical Trials

2,597,860 Total Patients Enrolled

McMaster Surgical AssociatesOTHER

16 Previous Clinical Trials

46,489 Total Patients Enrolled

Hamilton Health Sciences CorporationOTHER

368 Previous Clinical Trials

300,963 Total Patients Enrolled

Media Library

Glycerin Suppository Clinical Trial Eligibility Overview. Trial Name: NCT02153606 — N/A

Feeding Intolerance Research Study Groups: Glycerin Suppository, Sham Suppository

Feeding Intolerance Clinical Trial 2023: Glycerin Suppository Highlights & Side Effects. Trial Name: NCT02153606 — N/A

Glycerin Suppository 2023 Treatment Timeline for Medical Study. Trial Name: NCT02153606 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any fresh participants currently being sought for this investigation?

"As indicated on clinicaltrials.gov, this clinical trial is not enrolling participants at the present moment. The study was first uploaded in 2015 and its details were last updated in 2016. Despite this, there are 265 other medical studies actively recruiting candidates now."

Answered by AI

Could you elaborate on the research done concerning Glycerin Suppository?

"Currently, there are 4 trials for Glycerin Suppository with 1 of them in the late-stage phase 3. These studies can be found at 7 different sites across the United States; most notably San Antonio, Texas."

Answered by AI

What ailments have been addressed with Glycerin Suppository treatments?

"Glycerin Suppository has been identified as a potential treatment for dermabrasion, oral cavity issues and glaucoma suspects."

Answered by AI

What is the incidence of participators in this research?

"This clinical trial is no longer in search of participants, having been first posted on January 1st 2015 and last updated March 15th 2016. If you are looking for additional studies, 261 trials that relate to lactose intolerance as well as 4 Glycerin Suppository tests are currently enrolling patients."

Answered by AI

Recent research and studies

Pilot and Feasibility StudiesJournal

Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP) Trial: A Study Protocol for a Pilot Randomized Controlled Trial

Livingston, Michael H., Jorge Zequeira, Henrietta Blinder, Julia Pemberton, Connie Williams, and J Mark Walton. 2015. “Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP) Trial: A Study Protocol for a Pilot Randomized Controlled Trial”. Pilot and Feasibility Studies. Springer Science and Business Media LLC. doi:10.1186/s40814-015-0024-0.

clinicaltrials.govStudy

Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial

2015. "Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02153606.