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Role of Gastric acid suppressing medication in Prevention of Esophageal narrowing in operated neonates of Esophageal Atresia

Role of Proton Pump Inhibitors in prevention of Anastomotic Stricture in patients of Esophageal Atresia: A Pilot Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091255
Enrollment
40
Registered
2025-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: Q391- Atresia of esophagus with tracheo-esophageal fistula

Interventions

Intervention1: Surgery: Neonates receiving proton pump inhibitors(for a duration of 6 months post operatively)- to study its role in prevention of anastomotic stricture in operated neonates of esophag

Sponsors

Dr Aditya Shastri
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Neonates born at or after 35 weeks of gestation, in whom primary anastomosis has been done. 2. Neonates born at or after 35 weeks of gestation, without any associated anomalies.

Exclusion criteria

Exclusion criteria: 1. Neonates of Type C Esophageal Atresia undergoing Esophagostomy + Gastrostomy instead of primary anastomosis. 2. Neonates with anastomotic leak managed either conservatively or undergoing diversion procedure. 3. Other varieties of EA except Type-C. 4. Preterm babies with Type-C esophageal atresia.

Design outcomes

Primary

MeasureTime frame
To study the incidence of anastomotic stricture in operated cases of Esophageal atresia receiving Proton pump inhibitors and in control groupTimepoint: Till 6 months post operatively

Secondary

MeasureTime frame
To study the incidence of swallowing difficulty, episodes of respiratory infections, hospitalizations needed, requirement of dilatations in operated cases of Esophageal atresia receiving Proton pump ihibitors and in control groupTimepoint: Till 6 months post operatively

Countries

India

Contacts

Public ContactAditya Shastri

Post Graduate Institute of Medical Education and Research, Chandigarh

jkmahajan@gmail.com9417407077

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026