Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial

March 4, 2024 updated by: Emad Mohammad Khadawardi, King Faisal Specialist Hospital & Research Center
To evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (VLBW) infants

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital & Research Centre
      • Riyadh, Saudi Arabia
        • Security Forces Hospital
      • Riyadh, Saudi Arabia
        • Sulaiman Al habib Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Preterm infants with birth weight < 1250g.
  2. Inborn or outborn infants
  3. Less than 72 hours of age.

Exclusion Criteria:

  1. Congenital malformations.
  2. Acute abdomen needing surgical intervention.
  3. Severity of illness such that death is likely in the first few days after birth.
  4. Inability to get the parental consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention group will receive the glycerin suppository
Drug: Glycerin suppositories
No Intervention: Control
Normal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day)
Time Frame: 2years
2years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of feeding intolerance
Time Frame: 2years
which is defined by the presence of GRVs > 50 % of the previous feed for two consecutive feeds in addition to two of the following: I. Abdominal distention > 1 cm in 12 hour. II. Abdominal tenderness. III. Vomiting. IV. Bile stained aspirate.
2years
Incidence of necrotizing enterocolitis (NEC)
Time Frame: 2years
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Faisal Specialist Hospital & Research Center

Collaborators

Security Forces Hospital
Dr. Sulaiman Alhabib Medical City, Riyadh

Investigators

  • Principal Investigator: Emad M Khadawardi, MD, King Faisal Specialist Hospital & Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimated)

February 27, 2013

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2121 110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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