MedTrace Logo

Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries

NCT03302338 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-10-05

No results posted yet for this study

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.

Conditions

  • Necrotizing Enterocolitis

Interventions

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.

Sponsors & Collaborators

  • Rania Ali El-Farrash

    lead OTHER

Principal Investigators

  • Rania A El-Farrash, MD · ASU

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-06-30
Completion
2018-10-31

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03302338 on ClinicalTrials.gov