NCT03302338

Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries

Simulated Amniotic Fluid Like Solution Enterally Administrated in Neonates Recovering From GIT Surgeries

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

Summary

Amniotic fluid plays a significant role in fetal gut maturation and development. 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 neonates recovering from surgery for congenital bowel abnormalities, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in neonates recovering from GIT surgeries.

Detailed description

Neonates with congenital GIT anomalies will participate after being operated. Participants will be followed for the duration of hospital stay until discharge or death.

Conditions

• Necrotizing Enterocolitis

Interventions

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

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-06-01
• Completion: 2018-10-01
• First posted: 2017-10-05
• Last updated: 2017-10-05

Locations

1 site across 1 country: Egypt