NCT01799629

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

9.8 years

First QC Date

February 25, 2013

Last Update Submit

March 4, 2024

Conditions

Infant, Very Low Birth Weight

Keywords

Glycerin suppositoriesFeeding intolerancepreterm infantsprophylactic useelimination of meconium

Outcome Measures

Primary Outcomes (1)

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

    2years

Secondary Outcomes (2)

  • Incidence of feeding intolerance

    2years

  • Incidence of necrotizing enterocolitis (NEC)

    2years

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group will receive the glycerin suppository

Drug: Glycerin suppositories

Control

NO INTERVENTION

Normal care

Interventions

Glycerin suppositoriesDRUG
Intervention

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

King Faisal Specialist Hospital & Research Centre

Riyadh, 11211, Saudi Arabia

Location

Security Forces Hospital

Riyadh, Saudi Arabia

Location

Sulaiman Al habib Medical Center

Riyadh, Saudi Arabia

Location

Study Officials

  • Emad M Khadawardi, MD

    King Faisal Specialist Hospital & Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neonatology

Study Record Dates

First Submitted

February 25, 2013

First Posted

February 27, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

SA(3)