NCT02405637

Simulated Amniotic Fluid In Preventing Feeding Intolerance and Necrotizing Enterocolitis VLBW Neonates

Enteral Administration of a Simulated Amniotic Fluid In Preventing Feeding Intolerance And Necrotizing Enterocolitis In Very Low Birth Weight Neonates

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rania Ali El-Farrash · Academic / Other
• Sex: All
• Age: 28 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

Summary

The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel development.Growth factors found in the amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding intolerance is a common problem among premature neonates, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in premature neonates.

Detailed description

Very Low Birth Weight (VLBW) neonates. Participants will be followed for the duration of hospital stay until discharge or death.

Conditions

• Necrotizing Enterocolitis

Interventions

Type	Name	Description
DRUG	simulated amniotic fluid 20cc/kg/day enterally	simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
DRUG	distilled water	distilled water 20 ml/kg/day for maximum of 7 days.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-03-01
• Completion: 2015-05-01
• First posted: 2015-04-01
• Last updated: 2015-04-01

Locations

1 site across 1 country: Egypt