A Phase 1 interventional study of simulated amniotic fluid 20cc/kg/day enterally and distilled water in Necrotizing Enterocolitis, sponsored by Rania Ali El-Farrash. Status unknown at 1 site in Egypt. Open to participants aged 28 Weeks to 36 Weeks. Per ClinicalTrials.gov, last updated 2015-04-01.
Sponsored by Rania Ali El-Farrash · Phase 1, Interventional, and Prevention
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.
Very Low Birth Weight (VLBW) neonates.
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:
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: simulated amniotic fluid 20cc/kg/day enterally
distilled water 2.5 ml/kg every 3 hours enterally
Drug: distilled water
simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
Also known as: SAFE solution
distilled water 20 ml/kg/day for maximum of 7 days.
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
This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Rania Ali El-Farrash