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

Study Overview
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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.

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.

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

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Drug: simulated amniotic fluid 20cc/kg/day enterally
* Drug: distilled water


Participation Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAFE group<br>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. | Drug: simulated amniotic fluid 20cc/kg/day enterally<br>* simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.<br>* Other names: SAFE solution;|
| Placebo Comparator: placebo<br>distilled water 2.5 ml/kg every 3 hours enterally | Drug: distilled water<br>* distilled water 20 ml/kg/day for maximum of 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Necrotizing enterocolitis by modified Bell criteria, mortality in percentage, hospital stay in days. The outcome measure will be assessed within 2 months |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feeding intolerance, Simulated amniotic fluid, Necrotizing enterocolitis