NCT02149407

Brief Summary

Feeding intolerance is a common problem in preterm infants.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

May 20, 2014

Last Update Submit

April 2, 2015

Conditions

Feeding Intolerance

Outcome Measures

Primary Outcomes (1)

  • Time to full feeding (days)

    Days to achieve full enteral feeding

    Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Secondary Outcomes (5)

  • Incidence of feeding intolerance

    Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  • Incidence of necrotizing enterocolitis (NEC)

    Participants will be followed for the duration of hospital stay, an expected average of 8 weeks

  • Incidence of proven late onset infection

    Participants will be followed for the duration of hospital stay, an expected average of 8 weeks

  • Incidence of hyperbilirubinemia

    Participants will be followed for the duration of hospital stay, an expected average of 8 weeks

  • Length of hospital stay (days)

    At discharge from hospital, an expected average of 8 weeks

Other Outcomes (5)

  • Growth at discharge from hospital

    At discharge from hospital, an expected average of 8 weeks

  • Retinopathy of prematurity (ROP)

    Participants will be followed for the duration of hospital stay, an expected average of 8 weeks

  • Bronchopulmonary dysplasia (BPD)

    Participants will be followed for the duration of hospital stay, an expected average of 8 weeks

  • +2 more other outcomes

Study Arms (3)

Glycerin group (GG)

ACTIVE COMPARATOR

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

Rectal stimulation group (SG)

ACTIVE COMPARATOR

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

Control group (CG)

SHAM COMPARATOR

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

Interventions

GlycerinDRUG

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.

Also known as: Glycerine
Glycerin group (GG)
Rectal stimulationPROCEDURE

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.

Rectal stimulation group (SG)
ControlOTHER

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.

Control group (CG)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

King Saud Medical City

Riyadh, Saudi Arabia

RECRUITING

Sulaiman Al Habib Medical Group

Riyadh, Saudi Arabia

NOT YET RECRUITING

MeSH Terms

Interventions

Glycerol

Intervention Hierarchy (Ancestors)

Triose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Latifa Almahmoud, MD

    KSMC

    STUDY CHAIR

Central Study Contacts

Jasim Anabrees

CONTACT

jasim1800@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 29, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

SA(2)