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

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02405637
• Other study ID #: FMASU 7/2013
• Status: Recruiting
• Phase: Phase 1
• First received: February 23, 2015
• Last updated: March 28, 2015
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Ain Shams University
• Contact: Rania A El-Farrash, MD
• Phone: 00201222208550
• Email: raniafarrash[@]hotmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Very Low Birth Weight (VLBW) neonates.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 36 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Drug:
• simulated amniotic fluid 20cc/kg/day enterally
simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
• distilled water
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	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	No