Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries

Rania Ali El-Farrash

Status and phase: Unknown; Phase 1

Conditions: Necrotizing Enterocolitis

Treatments: Drug: placebo group; Drug: SAFE group

Study type: Interventional

Funder types: Other

Identifiers

NCT03302338

SAFE 2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neonates with operable congenital bowel abnormalities

Exclusion criteria

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

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:

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.

Treatment:

Drug: SAFE group

Placebo

Placebo Comparator group

Description:

Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.

Treatment:

Drug: placebo group