Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries

September 30, 2017 updated by: Rania Ali El-Farrash

Simulated Amniotic Fluid Like Solution Enterally Administrated in Neonates Recovering From GIT Surgeries

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 1138
        • Recruiting
        • ain shams University
        • Sub-Investigator:
          • safaa A El-aziz, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neonates with operable congenital bowel abnormalities

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SAFE group
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
simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
Other Names:
  • simulated amniotic fluid like solution 20cc/kg/day enterally
PLACEBO_COMPARATOR: Placebo
Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.
Drug: placebo group
distilled water 20 ml/kg/day for maximum of 7 days.
Other Names:
  • distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signs of feeding intolerance
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Necrotizing enterocolitis
Time Frame: The outcome measure will be assessed within 2 months
• 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).
The outcome measure will be assessed within 2 months
hospital stay
Time Frame: through study completion, an average of 1 year
duration on hospitalization
through study completion, an average of 1 year
mortality
Time Frame: he outcome measure will be assessed within 2 months
death
he outcome measure will be assessed within 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rania Ali El-Farrash

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

October 1, 2018

Study Registration Dates

First Submitted

May 17, 2015

First Submitted That Met QC Criteria

September 30, 2017

First Posted (ACTUAL)

October 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2017

Last Update Submitted That Met QC Criteria

September 30, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAFE 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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