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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAFE group | Experimental | 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 | Placebo Comparator | distilled water 2.5 ml/kg every 3 hours enterally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simulated amniotic fluid 20cc/kg/day enterally | Drug | simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Necrotizing enterocolitis by modified Bell criteria, mortality in percentage, hospital stay in days. The outcome measure will be assessed within 2 months | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rania A El-Farrash, MD | Contact | 00201222208550 | raniafarrash@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rania A El-Farrash, MD | ASU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | Cairo Governorate | 1138 | Egypt |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| distilled water | Drug | distilled water 20 ml/kg/day for maximum of 7 days. |
|
| D007410 |
| Intestinal Diseases |