Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants

Not Applicable

• Conditions: Feeding Intolerance
• Interventions: Other: Control; Drug: Glycerin; Procedure: Rectal stimulation

• Registration Number: NCT02149407
• Lead Sponsor: King Saud Medical City

Brief Summary

Feeding intolerance is a common problem in preterm infants.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-25
• Study First Posted: 2014-05-29
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-03
• Primary Completion: 2016-05
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (CG)	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.
Glycerin group (GG)	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.
Rectal stimulation group (SG)	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.

Primary Outcome Measures

Name	Time	Method
Time to full feeding (days)	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks	Days to achieve full enteral feeding

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay (days)	At discharge from hospital, an expected average of 8 weeks
Incidence of feeding intolerance	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.
Incidence of proven late onset infection	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.
Incidence of necrotizing enterocolitis (NEC)	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.
Incidence of hyperbilirubinemia	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.

Trial Locations

Locations (2)

King Saud Medical City; 🇸🇦 Riyadh, Saudi Arabia

Sulaiman Al Habib Medical Group; 🇸🇦 Riyadh, Saudi Arabia