Efficacy of Prophylactic Glycerin Suppositories for Feeding Intolerance in Very Low Birth Weight Preterm Infants: a Randomized Trial
Not Applicable
Terminated
- Conditions
- Infant, Very Low Birth Weight
- Interventions
- Registration Number
- NCT01799629
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
- Preterm infants with birth weight < 1250g.
- Inborn or outborn infants
- Less than 72 hours of age.
Exclusion Criteria
- Congenital malformations.
- Acute abdomen needing surgical intervention.
- Severity of illness such that death is likely in the first few days after birth.
- Inability to get the parental consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Glycerin suppositories Intervention group will receive the glycerin suppository
- Primary Outcome Measures
Name Time Method days to achieve full tolerated feeding (breast milk or formula) by NGT or by mouth (140cc/kg/day) 2years
- Secondary Outcome Measures
Name Time Method Incidence of feeding intolerance 2years 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.
Incidence of necrotizing enterocolitis (NEC) 2years
Trial Locations
- Locations (3)
King Faisal Specialist Hospital & Research Centre
🇸🇦Riyadh, Saudi Arabia
Sulaiman Al habib Medical Center
🇸🇦Riyadh, Saudi Arabia
Security Forces Hospital
🇸🇦Riyadh, Saudi Arabia