Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries

Study Overview
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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.

Official Title
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Simulated Amniotic Fluid Like Solution Enterally Administrated in Neonates Recovering From GIT Surgeries

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Drug: SAFE group
* Drug: placebo group


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 28 Days

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs of feeding intolerance | Feeding intolerance defined as distended loops of bowel, bilious vomiting, large pre-feeding gastric residuals more than 20% of each feed, diarrhea, occult or gross blood in stools, abdominal wall erythema or ecchymosis | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Necrotizing enterocolitis | • Clinical signs of suspected NEC (abdominal distension, increased volume of gastric aspirate, bile stained aspirate, and / or apnea or bradycardia), and Bell's modified criteria for staging (Bell et al., 1978). | The outcome measure will be assessed within 2 months | 
| hospital stay | duration on hospitalization | through study completion, an average of 1 year | 
| mortality | death | he outcome measure will be assessed within 2 months | 

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