CClinicalTrials.gg
TerminatedNCT01799629Updated Mar 6, 2024

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

An interventional study of Glycerin suppositories in Infant, Very Low Birth Weight, sponsored by King Faisal Specialist Hospital & Research Center. Terminated at 3 sites in Saudi Arabia. Open to participants aged Up to 1 Month, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by King Faisal Specialist Hospital & Research Center · Not applicable, Interventional, and Prevention

Why this study was terminated
Recruitment issue
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
Up to 1 Month
Sex
All
01

Study 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

02

Conditions studied

  • Infant, Very Low Birth Weight

Keywords

  • Glycerin suppositories
  • Feeding intolerance
  • preterm infants
  • prophylactic use
  • elimination of meconium
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 220 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

King Faisal Specialist Hospital & Research Center is the lead sponsor of 98 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 1 Month
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    Intervention

    Intervention group will receive the glycerin suppository

    Drug: Glycerin suppositories

  • No intervention
    Control

    Normal care

Interventions

  • DrugGlycerin suppositories
06

What researchers measure

Primary outcomes

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

    Time frame: 2years

Secondary outcomes

  1. 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.

    Time frame: 2years

  2. Incidence of necrotizing enterocolitis (NEC)

    Time frame: 2years

07

Study locations

3 sites
  • King Faisal Specialist Hospital & Research Centre
    Riyadh, 11211, Saudi Arabia
  • Security Forces Hospital
    Riyadh, Saudi Arabia
  • Sulaiman Al habib Medical Center
    Riyadh, Saudi Arabia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01799629
Lead sponsor
King Faisal Specialist Hospital & Research Center
Collaborators
Dr. Sulaiman Alhabib Medical City, Riyadh, Security Forces Hospital
Responsible party
Emad Mohammad Khadawardi (Consultant Neonatology, King Faisal Specialist Hospital & Research Center) — Principal investigator
First posted
Feb 27, 2013
Start date
Mar 2013
Primary completion
Dec 2022
Completion
Dec 2022
Last update
Mar 6, 2024

Study contacts

Emad M Khadawardi, MD
principal investigator · King Faisal Specialist Hospital & Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion