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

NCT02405637 | Unknown Phase 1 DMC

• 1 other identifier: FMASU 7/2013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Enterocolitis

Keywords

Feeding intolerance; Simulated amniotic fluid; Necrotizing enterocolitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SAFE group

EXPERIMENTAL

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: simulated amniotic fluid 20cc/kg/day enterally

placebo

PLACEBO COMPARATOR

distilled water 2.5 ml/kg every 3 hours enterally

Drug: distilled water

Interventions

simulated amniotic fluid 20cc/kg/day enterally DRUG

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

Also known as: SAFE solution

SAFE group

distilled water DRUG

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

placebo

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants with birth weight 1.5 Kg

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Rania Ali El-Farrash: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 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: Enteral Administration of a Simulated Amniotic Fluid In Preventing Feeding Intolerance And Necrotizing Enterocolitis In Very Low Birth Weight Neonates

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: April 1, 2015
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

EG (1)