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

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

2014-03-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Very Low Birth Weight (VLBW) neonates.

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

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

simulated amniotic fluid 20cc/kg/day enterally

Intervention Type DRUG

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

placebo

distilled water 2.5 ml/kg every 3 hours enterally

Group Type PLACEBO_COMPARATOR

distilled water

Intervention Type DRUG

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

Interventions

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simulated amniotic fluid 20cc/kg/day enterally

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

Intervention Type DRUG

distilled water

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

Intervention Type DRUG

Other Intervention Names

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SAFE solution

Eligibility Criteria

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Inclusion Criteria

* Premature infants with birth weight 1.5 Kg

Exclusion Criteria

* Congenital or acquired anomaly of the gastrointestinal tract (i.e., omphalocele, tracheoesophageal fistula, intestinal perforation).
* Other major congenital anomalies (congenital heart disease, neural tube defect, congenital diaphragmatic hernia, trisomy, etc.).

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rania Ali El-Farrash

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

Responsibility Role SPONSOR_INVESTIGATOR