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

• Sponsor: King Faisal Specialist Hospital & Research Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01799629
• Collaborator: Dr. Sulaiman Alhabib Medical City, Riyadh (Other), Security Forces Hospital (Other)
• Enrollment: 220
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 118
• Patients Per Site: 73.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Actual Study Start Date: Mar 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Incidence of feeding intolerance [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) [2years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Month
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	King Faisal Specialist Hospital & Research Centre	Riyadh		Saudi Arabia	11211
2	Security Forces Hospital	Riyadh		Saudi Arabia
3	Sulaiman Al habib Medical Center	Riyadh		Saudi Arabia

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emad Mohammad Khadawardi, Consultant Neonatology, King Faisal Specialist Hospital & Research Center
• ClinicalTrials.gov Identifier: NCT01799629
• Other Study ID Numbers: 2121 110
• First Posted: Feb 27, 2013
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Emad Mohammad Khadawardi, Consultant Neonatology, 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; Glycerol

Study Results

No Results Posted as of Mar 31, 2022