A Phase 1 interventional study of SAFE group and placebo group in Necrotizing Enterocolitis, sponsored by Rania Ali El-Farrash. Status unknown at 1 site in Egypt. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2017-10-05.
Sponsored by Rania Ali El-Farrash · Phase 1, Interventional, and Prevention
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.
Neonates with congenital GIT anomalies will participate after being operated.
Participants will be followed for the duration of hospital stay until discharge or death.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 40 is below the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Rania Ali El-Farrash is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.
Drug: placebo group
simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
Also known as: simulated amniotic fluid like solution 20cc/kg/day enterally
distilled water 20 ml/kg/day for maximum of 7 days.
Also known as: distilled water
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
Time frame: through study completion, an average of 1 year
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).
Time frame: The outcome measure will be assessed within 2 months
hospital stay
duration on hospitalization
Time frame: through study completion, an average of 1 year
mortality
death
Time frame: he outcome measure will be assessed within 2 months
Started Jul 2015 (actual). Primary completion is estimated for Jun 2018, 35 months after the start.
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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Rania Ali El-Farrash