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

K

King Faisal Specialist Hospital & Research Center

Status

Terminated

Conditions

Infant, Very Low Birth Weight

Treatments

Drug: Glycerin suppositories

Study type

Interventional

Funder types

Other

Identifiers

NCT01799629
2121 110

Details and patient eligibility

About

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

Enrollment

220 patients

Sex

All

Ages

Under 1 month old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Preterm infants with birth weight < 1250g.
  2. Inborn or outborn infants
  3. Less than 72 hours of age.

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 2 patient groups

Intervention
Experimental group
Description:
Intervention group will receive the glycerin suppository
Treatment:
Drug: Glycerin suppositories
Control
No Intervention group
Description:
Normal care

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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