Back to resultsSimulated Amniotic Fluid In Preventing Feeding Intolerance and Necrotizing Enterocolitis VLBW Neonates
Primary Purpose
Necrotizing Enterocolitis
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
simulated amniotic fluid 20cc/kg/day enterally
distilled water
Sponsored by
About this trial
This is an interventional prevention trial for Necrotizing Enterocolitis focused on measuring Feeding intolerance, Simulated amniotic fluid, Necrotizing enterocolitis
Eligibility Criteria
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.).
Sites / Locations
- Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SAFE group
placebo
Arm Description
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.
distilled water 2.5 ml/kg every 3 hours enterally
Outcomes
Primary Outcome Measures
Necrotizing enterocolitis by modified Bell criteria, mortality in percentage, hospital stay in days. The outcome measure will be assessed within 2 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02405637
Brief Title
Simulated Amniotic Fluid In Preventing Feeding Intolerance and Necrotizing Enterocolitis VLBW Neonates
Official Title
Enteral Administration of a Simulated Amniotic Fluid In Preventing Feeding Intolerance And Necrotizing Enterocolitis In Very Low Birth Weight Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rania Ali El-Farrash
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Very Low Birth Weight (VLBW) neonates.
Participants will be followed for the duration of hospital stay until discharge or death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis
Keywords
Feeding intolerance, Simulated amniotic fluid, Necrotizing enterocolitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SAFE group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
distilled water 2.5 ml/kg every 3 hours enterally
Intervention Type
Drug
Intervention Name(s)
simulated amniotic fluid 20cc/kg/day enterally
Other Intervention Name(s)
SAFE solution
Intervention Description
simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
Intervention Type
Drug
Intervention Name(s)
distilled water
Intervention Description
distilled water 20 ml/kg/day for maximum of 7 days.
Primary Outcome Measure Information:
Title
Necrotizing enterocolitis by modified Bell criteria, mortality in percentage, hospital stay in days. The outcome measure will be assessed within 2 months
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania A El-Farrash, MD
Phone
00201222208550
Email
raniafarrash@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania A El-Farrash, MD
Organizational Affiliation
ASU
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
1138
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rania A El-Farrash, MD
Phone
00201222208550
Email
raniafarrash@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed S Auda, Msc
12. IPD Sharing Statement
Learn more about this trial
Simulated Amniotic Fluid In Preventing Feeding Intolerance and Necrotizing Enterocolitis VLBW Neonates
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