Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03302338
• Other study ID #: SAFE 2013
• Status: Recruiting
• Phase: Phase 1
• First received: May 17, 2015
• Last updated: September 30, 2017
• Start date: July 2015
• Est. completion date: October 2018

Study information

• Verified date: September 2017
• Source: Ain Shams University
• Contact: Rania A El-Farrash, MD
• Phone: 00201222208550
• Email: raniafarrash[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Neonates with operable congenital bowel abnormalities

Exclusion Criteria:

• Critically ill babies.

• Presence of any contraindications to enteral feeding

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Drug:
• SAFE group
simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
• placebo group
distilled water 20 ml/kg/day for maximum of 7 days.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Rania Ali El-Farrash

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	hospital stay	duration on hospitalization	through study completion, an average of 1 year
Secondary	mortality	death	he outcome measure will be assessed within 2 months