Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants

April 2, 2015 updated by: King Saud Medical City

Efficacy and Safety of Glycerin Suppositories for Treatment of Feeding Intolerance in Very Low Birth Weight Infants

Feeding intolerance is a common problem in preterm infants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Recruiting
        • King Saud Medical City
        • Contact:
        • Principal Investigator:
          • latifa Almahmoud
        • Sub-Investigator:
          • Haider Somaily
        • Sub-Investigator:
          • Nabeel Al-Odaisan
        • Sub-Investigator:
          • Sadia Al-Shehri
      • Riyadh, Saudi Arabia
        • Not yet recruiting
        • Sulaiman Al Habib Medical Group
        • Contact:
        • Principal Investigator:
          • Jasim Anabrees, FRCPCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Preterm infants with birth weight equal or less than 1500 g

Exclusion Criteria:

  • Significant congenital malformations
  • Severity of illness such that death is likely in the first few days after birth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glycerin group (GG)
Glycerin group "GG" will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery.
Drug: Glycerin
Glycerin group "GG" will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery.
Other Names:
  • Glycerine
Active Comparator: Rectal stimulation group (SG)
Rectal stimulation "SG" by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall.
Procedure: Rectal stimulation
Rectal stimulation "SG" by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall.
Sham Comparator: Control group (CG)
Control group "CG" will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes.
Other: Control
Control group "CG" will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to full feeding (days)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Days to achieve full enteral feeding
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of feeding intolerance
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Feeding intolerance defined as feeding withheld, discontinued, or decreased because the infant was not tolerating enteral feedings.
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Incidence of necrotizing enterocolitis (NEC)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Necrotizing enterocolitis (NEC) defined as per Bell's staging.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Incidence of proven late onset infection
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Incidence of proven late onset infection defined as clinical signs in addition to positive blood culture beyond 72 hours of age.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Incidence of hyperbilirubinemia
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Incidence of hyperbilirubinemia defined as level of bilirubin requiring treatment with phototherapy according to the bilirubin chart used in the participating unit.
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Length of hospital stay (days)
Time Frame: At discharge from hospital, an expected average of 8 weeks
At discharge from hospital, an expected average of 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth at discharge from hospital
Time Frame: At discharge from hospital, an expected average of 8 weeks
Growth parameters at discharge from hospital include: Weight (grams), Length (cm), and Head circumference (cm)
At discharge from hospital, an expected average of 8 weeks
Retinopathy of prematurity (ROP)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Defined by the International Classification of Retinopathy of Prematurity (ICORP)
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Bronchopulmonary dysplasia (BPD)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Patent ductus arteriosus (PDA)
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Diagnosed by echocardiogram
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Side effects
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
For example: Rectal bleeding, Rectal Perforation, or Hematochezia
Participants will be followed for the duration of hospital stay, an expected average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud Medical City

Collaborators

Sulaiman Al Habib Medical Group- Arrayan Hospital

Investigators

  • Study Chair: Latifa Almahmoud, MD, KSMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 25, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0752

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Feeding Intolerance

Clinical Trials on Glycerin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe