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Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries

NCT ID: NCT03302338

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-10-31

Brief Summary

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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

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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

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Necrotizing Enterocolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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SAFE group

SAFE group: simulated amniotic fluid 20cc/kg/day enterally divided according to number of feds (syringe for every fed). This amount provides enteral 4.5μg rhG-CSF / kg/day and enteral 88IU rhEPO / kg/day.

Group Type EXPERIMENTAL

SAFE group

Intervention Type DRUG

simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.

Placebo

Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.

Group Type PLACEBO_COMPARATOR

placebo group

Intervention Type DRUG

distilled water 20 ml/kg/day for maximum of 7 days.

Interventions

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SAFE group

simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.

Intervention Type DRUG

placebo group

distilled water 20 ml/kg/day for maximum of 7 days.

Intervention Type DRUG

Other Intervention Names

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simulated amniotic fluid like solution 20cc/kg/day enterally distilled water

Eligibility Criteria

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Inclusion Criteria

* Neonates with operable congenital bowel abnormalities

Exclusion Criteria

* Critically ill babies.
* Presence of any contraindications to enteral feeding
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rania Ali El-Farrash

OTHER

Sponsor Role lead

Responsible Party

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Rania Ali El-Farrash

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rania A El-Farrash, MD

Role: STUDY_DIRECTOR

ASU

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rania A El-Farrash, MD

Role: CONTACT

[email protected]
00201222208550

Facility Contacts

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Rania A El-Farrash, MD

Role: primary

[email protected]
00201222208550

Other Identifiers

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SAFE 2013

Identifier Type: -

Identifier Source: org_study_id