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

Phase 1

• Conditions: Necrotizing Enterocolitis
• Interventions: Drug: simulated amniotic fluid 20cc/kg/day enterally; Drug: distilled water

• Registration Number: NCT02405637
• Lead Sponsor: Rania Ali El-Farrash

Brief 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.

Detailed Description

Very Low Birth Weight (VLBW) neonates.

Participants will be followed for the duration of hospital stay until discharge or death.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2015-02-23
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study First Submitted QC: 2015-03-28
• Last Update Submitted: 2015-03-28
• Study First Posted: 2015-04-01
• Last Update Posted: 2015-04-01
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAFE group	simulated amniotic fluid 20cc/kg/day enterally	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.
placebo	distilled water	distilled water 2.5 ml/kg every 3 hours enterally

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt