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

NCT02405637 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-04-01

No results posted yet for this study

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.

Conditions

  • Necrotizing Enterocolitis

Interventions

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.

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

Min Age
28 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-03-31
Completion
2015-05-31

Countries

  • Egypt

Study Locations

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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 NCT02405637 on ClinicalTrials.gov