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

Enteral Administration of a Simulated Amniotic Fluid In Preventing Feeding Intolerance And Necrotizing Enterocolitis In Very Low Birth Weight Neonates

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02405637

Enrollment

Registered

2015-04-01

Start date

2014-03-31

Completion date

2015-05-31

Last updated

2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis

Keywords

Feeding intolerance, Simulated amniotic fluid, Necrotizing enterocolitis

Brief summary

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.

Detailed description

Very Low Birth Weight (VLBW) neonates. Participants will be followed for the duration of hospital stay until discharge or death.

Interventions

DRUGsimulated amniotic fluid 20cc/kg/day enterally

simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.

DRUGdistilled water

distilled water 20 ml/kg/day for maximum of 7 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

28 Weeks to 36 Weeks

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.).

Design outcomes

Primary

Measure	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

Countries

Egypt

Contacts

Primary ContactRania A El-Farrash, MD

raniafarrash@hotmail.com00201222208550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026