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

Primary Purpose

Infant, Very Low Birth Weight

Status

Recruiting

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Glycerin suppositories

About this trial

This is an interventional prevention trial for Infant, Very Low Birth Weight focused on measuring Glycerin suppositories, Feeding intolerance, preterm infants, prophylactic use, elimination of meconium

Eligibility Criteria

undefined - 1 Month (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

King Faisal Specialist Hospital & Research CentreRecruiting
Security Forces Hospital
Sulaiman Al habib Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Intervention group will receive the glycerin suppository

Normal care

Outcomes

Primary Outcome Measures

days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day)

Secondary Outcome Measures

Incidence of feeding intolerance

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)

Full Information

NCT ID

NCT01799629

First Posted

February 25, 2013

Last Updated

March 28, 2022

Sponsor

King Faisal Specialist Hospital & Research Center

Collaborators

Dr. Sulaiman Alhabib Medical City, Riyadh, Security Forces Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01799629

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 2013 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Faisal Specialist Hospital & Research Center

Collaborators

Dr. Sulaiman Alhabib Medical City, Riyadh, Security Forces Hospital

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant, Very Low Birth Weight

Keywords

Glycerin suppositories, Feeding intolerance, preterm infants, prophylactic use, elimination of meconium

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Intervention group will receive the glycerin suppository

Arm Title

Control

Arm Type

No Intervention

Arm Description

Normal care

Intervention Type

Drug

Intervention Name(s)

Glycerin suppositories

Primary Outcome Measure Information:

Title

days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day)

Time Frame

2years

Secondary Outcome Measure Information:

Title

Incidence of feeding intolerance

Description

Time Frame

2years

Title

Incidence of necrotizing enterocolitis (NEC)

Time Frame

2years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

1 Month

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Preterm infants with birth weight < 1250g. Inborn or outborn infants Less than 72 hours of age. Exclusion Criteria: Congenital malformations. Acute abdomen needing surgical intervention. Severity of illness such that death is likely in the first few days after birth. Inability to get the parental consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emad M Khadawardi, MD

Organizational Affiliation

King Faisal Specialist Hospital & Research Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

King Faisal Specialist Hospital & Research Centre

City

Riyadh

ZIP/Postal Code

11211

Country

Saudi Arabia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eamd m Khadawardi, MD

Phone

00966505541843

ekhadawardi@kfshrc.edu.sa

First Name & Middle Initial & Last Name & Degree

Emad M Khadawardi, MD

First Name & Middle Initial & Last Name & Degree

Eyad Almidani, MD

First Name & Middle Initial & Last Name & Degree

Khalid Al-Faleh, MD

First Name & Middle Initial & Last Name & Degree

Khalid Alhussain, MD

First Name & Middle Initial & Last Name & Degree

Jasim Anabrees, MD

Facility Name

Security Forces Hospital

City

Riyadh

Country

Saudi Arabia

Individual Site Status

Completed

Facility Name

Sulaiman Al habib Medical Center

City

Riyadh

Country

Saudi Arabia

Individual Site Status

Completed

12. IPD Sharing Statement

Learn more about this trial

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

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