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

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ClinicalTrials.gov Identifier: NCT01799629
Recruitment Status : Recruiting
First Posted : February 27, 2013
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
Dr. Sulaiman Alhabib Medical City, Riyadh
Security Forces Hospital
Information provided by (Responsible Party):
Emad Mohammad Khadawardi, King Faisal Specialist Hospital & Research Center

Brief Summary:
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 or disease Intervention/treatment Phase
Infant, Very Low Birth Weight Drug: Glycerin suppositories Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
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
Study Start Date : March 2013
Estimated Primary Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Glycerin
U.S. FDA Resources

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



Primary Outcome Measures :
  1. days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day) [ Time Frame: 2years ]

Secondary Outcome Measures :
  1. 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.

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


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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.

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

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 Posted: February 27, 2013    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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