Glycerin Suppositories for Treatment of Feeding Intolerance in Preterm Infants

King Saud Medical City

Status: Unknown

Conditions: Feeding Intolerance

Treatments: Drug: Glycerin; Other: Control; Procedure: Rectal stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02149407

0752

Details and patient eligibility

About

Feeding intolerance is a common problem in preterm infants.

Enrollment: 230 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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230 participants in 3 patient groups

Glycerin group (GG)

Active Comparator group

Description:

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.

Treatment:

Drug: Glycerin

Rectal stimulation group (SG)

Active Comparator group

Description:

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.

Treatment:

Procedure: Rectal stimulation

Control group (CG)

Sham Comparator group

Description:

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.

Treatment:

Other: Control