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Effect of Giving Oral Rehydration Solution Through the Distal Mucous Fistula in Babies with Enterostomy: A Randomized Study

Effect of administration of Oral rehydration solution through distal mucous fistula in neonates with enterostomies:-a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109364
Enrollment
60
Registered
2026-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: P779- Necrotizing enterocolitis in newborn, unspecified Health Condition 2: P781- Other neonatal peritonitis

Interventions

Intervention1: Adminstration of Oral Rehydration Solution through Distal Mucous Fistula in Neonates with Enterostomies: ORS will be prepared by dissolving 1packet of ORS (available at every local go

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.proximal small-bowel enterostomy and accessible distal mucous fistula after intestinal resection like NEC,atresia, gastroschisis 2.clinically stable

Exclusion criteria

Exclusion criteria: 1.Major congenital anomalies incompatible with survival. 2.Distal obstruction ,distal perforation.and on the basis of intraoperative findings 3.Grossly ischemic distal bowel judged by surgeon. 4.Neonates undergoing colostomy because of anorectal malformations and Hirschsprung s disease 5.Mechanical difficulty. 6.Complex cardiac anomaly

Design outcomes

Primary

MeasureTime frame
To assess incidence of hyponatremia in neonates and infantsTimepoint: 1 AND 3 MONTHS

Secondary

MeasureTime frame
1. Weight gain at 1month and 3 months postoperatively in both the groups. 2. Urine sodium at 1 and 3 months postoperatively in both the groups. 3. Readmission during 3 months post surgery. 4. Time to regain gut motility after stoma closure. 5. Success of stoma closure. 6. Complications related to distal ors administration (i.e trauma, abdomoinal distention). 7.venous blood gas analysis Timepoint: 1 AND 3 MONTHS

Countries

India

Contacts

Public ContactDr Gurinder Kaur

PGIMER Chandigarh

drgurinderkaur2010@gmail.com9646244248

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026