Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries

Phase 1

• Conditions: Necrotizing Enterocolitis
• Interventions: Drug: placebo group; Drug: SAFE group

• Registration Number: NCT03302338
• Lead Sponsor: Rania Ali El-Farrash

Brief Summary

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

Neonates with congenital GIT anomalies will participate after being operated.

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

Study Timeline

• Study First Submitted: 2015-05-17
• Study Start: 2015-07
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-30
• Last Update Submitted: 2017-09-30
• Study First Posted: 2017-10-05
• Last Update Posted: 2017-10-05
• Primary Completion: 2018-06
• Study Completion: 2018-10

Recruitment & Eligibility

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

Inclusion Criteria

• Neonates with operable congenital bowel abnormalities

Exclusion Criteria

• Critically ill babies.
• Presence of any contraindications to enteral feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo group	Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.
SAFE group	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.

Primary Outcome Measures

Name	Time	Method
Signs of feeding intolerance	through study completion, an average of 1 year	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

Secondary Outcome Measures

Name	Time	Method
mortality	he outcome measure will be assessed within 2 months	death
hospital stay	through study completion, an average of 1 year	duration on hospitalization
Necrotizing enterocolitis	The outcome measure will be assessed within 2 months	• 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).

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt