Necrotizing Enterocolitis
Conditions
Keywords
Feeding intolerance, Simulated amniotic fluid like solution, Necrotizing enterocolitis
Brief summary
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.
Detailed 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.
Interventions
DRUGSAFE group
simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
DRUGplacebo group
distilled water 20 ml/kg/day for maximum of 7 days.
Sponsors
Rania Ali El-Farrash
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
Inclusion criteria
* Neonates with operable congenital bowel abnormalities
Exclusion criteria
* Critically ill babies. * Presence of any contraindications to enteral feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signs of feeding intolerance | through study completion, an average of 1 year | Feeding intolerance defined as distended loops of bowel, bilious vomiting, large pre-feeding gastric residuals more than 20% of each feed, diarrhea, occult or gross blood in stools, abdominal wall erythema or ecchymosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Necrotizing enterocolitis | The outcome measure will be assessed within 2 months | • Clinical signs of suspected NEC (abdominal distension, increased volume of gastric aspirate, bile stained aspirate, and / or apnea or bradycardia), and Bell's modified criteria for staging (Bell et al., 1978). |
| hospital stay | through study completion, an average of 1 year | duration on hospitalization |
| mortality | he outcome measure will be assessed within 2 months | death |
Countries
Egypt
Contacts
Primary ContactRania A El-Farrash, MD
Outcome results
None listed