Simulated Amniotic Fluid In Preventing Feeding Intolerance and Necrotizing Enterocolitis VLBW Neonates

Rania Ali El-Farrash

Status and phase: Unknown; Phase 1

Conditions: Necrotizing Enterocolitis

Treatments: Drug: distilled water; Drug: simulated amniotic fluid 20cc/kg/day enterally

Study type: Interventional

Funder types: Other

Identifiers

NCT02405637

FMASU 7/2013

Details and patient eligibility

About

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.

Full description

Very Low Birth Weight (VLBW) neonates.

Participants will be followed for the duration of hospital stay until discharge or death.

Enrollment: 40 estimated patients

Sex: All

Ages: 28 to 36 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Premature infants with birth weight 1.5 Kg

Exclusion criteria

• Congenital or acquired anomaly of the gastrointestinal tract (i.e., omphalocele, tracheoesophageal fistula, intestinal perforation).
• Other major congenital anomalies (congenital heart disease, neural tube defect, congenital diaphragmatic hernia, trisomy, etc.).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

SAFE group

Experimental group

Description:

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.

Treatment:

Drug: simulated amniotic fluid 20cc/kg/day enterally

placebo

Placebo Comparator group

Description:

distilled water 2.5 ml/kg every 3 hours enterally

Treatment:

Drug: distilled water