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

King Faisal Specialist Hospital & Research Center220 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

220

Conditions

Infant, Very Low Birth Weight

Interventions

Glycerin suppositoriesDRUG

Eligibility

Sex: ALLMax age: 1 MonthHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

King Faisal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia

Security Forces Hospital

Riyadh, Saudi Arabia

Sulaiman Al habib Medical Center

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day)

Time frame: 2years

Secondary Outcomes

Incidence of feeding intolerance

which is defined by the presence of GRVs \> 50 % of the previous feed for two consecutive feeds in addition to two of the following: I. Abdominal distention \> 1 cm in 12 hour. II. Abdominal tenderness. III. Vomiting. IV. Bile stained aspirate.

Time frame: 2years

Incidence of necrotizing enterocolitis (NEC)

Time frame: 2years

Data from ClinicalTrials.gov

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