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

This study is currently recruiting participants.
Verified April 2013 by King Faisal Specialist Hospital & Research Center
Sponsor:
Collaborator:
Sulaiman Al habib Medical Center
Information provided by (Responsible Party):
Emad Mohammad Khadawardi, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01799629
First received: February 25, 2013
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Infant, Very Low Birth Weight
Drug: Glycerin suppositories

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:
  • days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day) [ Time Frame: 2years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of feeding intolerance [ Time Frame: 2years ] [ Designated as safety issue: No ]
    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.

  • Incidence of necrotizing enterocolitis (NEC) [ Time Frame: 2years ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: March 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Intervention group will receive the glycerin suppository
Drug: Glycerin suppositories
No Intervention: Control
Normal care

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799629

Locations
Saudi Arabia
King Faisal Specialist Hospital & Research Centre Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Eamd m Khadawardi, MD    00966505541843    ekhadawardi@kfshrc.edu.sa   
Principal Investigator: Emad m Khadawardi, MD         
Sub-Investigator: Jasim Anabrees, MD         
Sub-Investigator: Khalid Al-Faleh, MD         
Sub-Investigator: Eyad M Almidani         
Sulaiman Al habib Medical Center Recruiting
Riyadh, Saudi Arabia
Contact: Jasim Anabrees, MD    00966590591102    jasim1800@yahoo.com   
Sub-Investigator: Jasim Anabrees, MD         
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Sulaiman Al habib Medical Center
Investigators
Principal Investigator: Emad M Khadawardi, MD King Faisal Specialist Hospital & Research Centre
  More Information

No publications provided

Responsible Party: Emad Mohammad Khadawardi, Consultant Neonatology, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01799629     History of Changes
Other Study ID Numbers: 2121 110
Study First Received: February 25, 2013
Last Updated: April 11, 2013
Health Authority: Saudi Arabia: Ethics Committee

Keywords provided by King Faisal Specialist Hospital & Research Center:
Glycerin suppositories
Feeding intolerance
preterm infants
prophylactic use
elimination of meconium

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014