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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 August 2016 by Emad Mohammad Khadawardi, King Faisal Specialist Hospital & Research Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01799629
First Posted: February 27, 2013
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Dr. Sulaiman Alhabib Medical City, Riyadh
Security Forces Hospital
Information provided by (Responsible Party):
Emad Mohammad Khadawardi, King Faisal Specialist Hospital & Research Center
  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: None (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 Emad Mohammad Khadawardi, 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 ]

Secondary Outcome Measures:
  • 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.

  • Incidence of necrotizing enterocolitis (NEC) [ Time Frame: 2years ]

Estimated Enrollment: 220
Study Start Date: March 2013
Estimated Primary Completion Date: September 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
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
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): 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: Eyad Almidani, MD         
Sub-Investigator: Khalid Al-Faleh, MD         
Sub-Investigator: Khalid Alhussain, MD         
Sub-Investigator: Jasim Anabrees, MD         
Security Forces Hospital Recruiting
Riyadh, Saudi Arabia
Contact: Khalid Alhussain, MD       kalhussein9@hotmail.com   
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
Dr. Sulaiman Alhabib Medical City, Riyadh
Security Forces Hospital
Investigators
Principal Investigator: Emad M Khadawardi, MD King Faisal Specialist Hospital & Research Centre
  More Information

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
First Submitted: February 25, 2013
First Posted: February 27, 2013
Last Update Posted: August 31, 2016
Last Verified: August 2016

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

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