Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries

NCT03302338 | Unknown Phase 1 DMC

• 1 other identifier: SAFE 2013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Enterocolitis

Keywords

Feeding intolerance; Simulated amniotic fluid like solution; Necrotizing enterocolitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Necrotizing enterocolitis

  The outcome measure will be assessed within 2 months

• hospital stay

  through study completion, an average of 1 year

• mortality

  he outcome measure will be assessed within 2 months

Study Arms (2)

SAFE group

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.

Drug: placebo group

Interventions

SAFE group DRUG

simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.

Also known as: simulated amniotic fluid like solution 20cc/kg/day enterally

SAFE group

placebo group DRUG

distilled water 20 ml/kg/day for maximum of 7 days.

Also known as: distilled water

Placebo

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with operable congenital bowel abnormalities

You may not qualify if:

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

Sponsors & Collaborators

• Rania Ali El-Farrash: lead

Study Sites (1)

Ain Shams University

Cairo, 1138, Egypt

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Rania A El-Farrash, MD

  ASU

  STUDY DIRECTOR

Central Study Contacts

Rania A El-Farrash, MD

CONTACT

00201222208550; raniafarrash@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 17, 2015
• First Posted: October 5, 2017
• Study Start: July 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 5, 2017

Record last verified: 2017-09

Locations

EG (1)