Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries
Primary Purpose
Necrotizing Enterocolitis
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
SAFE group
placebo group
Sponsored by
About this trial
This is an interventional prevention trial for Necrotizing Enterocolitis focused on measuring Feeding intolerance, Simulated amniotic fluid like solution, Necrotizing enterocolitis
Eligibility Criteria
Inclusion Criteria:
- Neonates with operable congenital bowel abnormalities
Exclusion Criteria:
- Critically ill babies.
- Presence of any contraindications to enteral feeding
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
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.
Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
hospital stay
duration on hospitalization
mortality
death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03302338
Brief Title
Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries
Official Title
Simulated Amniotic Fluid Like Solution Enterally Administrated in Neonates Recovering From GIT Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
October 2018 (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
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.
Detailed 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.
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 like solution, 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
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.
Intervention Type
Drug
Intervention Name(s)
SAFE group
Other Intervention Name(s)
simulated amniotic fluid like solution 20cc/kg/day enterally
Intervention Description
simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
Intervention Type
Drug
Intervention Name(s)
placebo group
Other Intervention Name(s)
distilled water
Intervention Description
distilled water 20 ml/kg/day for maximum of 7 days.
Primary Outcome Measure Information:
Title
Signs of feeding intolerance
Description
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
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Necrotizing enterocolitis
Description
• 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).
Time Frame
The outcome measure will be assessed within 2 months
Title
hospital stay
Description
duration on hospitalization
Time Frame
through study completion, an average of 1 year
Title
mortality
Description
death
Time Frame
he outcome measure will be assessed within 2 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neonates with operable congenital bowel abnormalities
Exclusion Criteria:
Critically ill babies.
Presence of any contraindications to enteral feeding
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
safaa A El-aziz, Msc
12. IPD Sharing Statement
Learn more about this trial
Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries
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