| CTRI Number |
CTRI/2025/07/091255 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Gastric acid suppressing medication in Prevention of Esophageal narrowing in operated neonates of Esophageal Atresia |
|
Scientific Title of Study
|
Role of Proton Pump Inhibitors in prevention of Anastomotic Stricture in patients of Esophageal Atresia: A Pilot Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Shastri |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Advanced Paediatric Centre, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9769496525 |
| Fax |
|
| Email |
mots0811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jai Kumar Mahajan |
| Designation |
Professor and Head |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Advanced Paediatric Centre, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417407077 |
| Fax |
|
| Email |
jkmahajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Shastri |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Advanced Paediatric Centre, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9769496525 |
| Fax |
|
| Email |
mots0811@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thesis funds, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012 |
|
|
Primary Sponsor
|
| Name |
Dr Aditya Shastri |
| Address |
Department of Paediatric Surgery, Advanced Paediatric Centre, Post Graduate Institute of Medical Education & Research, Chandigarh-160012, India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aditya Shastri |
Post Graduate Institute of Medical Education and Research |
Department of Paediatric Surgery, Post Graduate Institute of Medical Education and Research, Chandigarh 160012
Chandigarh
CHANDIGARH |
9769496525
mots0811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(INTRAMURAL), Post Graduate Institute of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q391||Atresia of esophagus with tracheo-esophageal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Surgery |
Neonates operated for esophageal atresia receiving a placebo(for a duration of 6 months post operatively). |
| Intervention |
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 esophageal atresia. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of anastomotic stricture in operated cases of Esophageal atresia receiving Proton pump inhibitors and in control group |
Till 6 months post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 group |
Till 6 months post operatively |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A pilot randomized controlled trial to evaluate the efficacy of Proton pump inhibitors in reducing the incidence of anastomotic stricture in operated neonates of Esophageal atresia and to study their effect on the gut microbiome. This study will also assess the impact of Proton pump inhibitors on clinical symptoms after discharge such as swallowing difficulty, episodes of respiratory infections, number of hospitalisations needed and requirement of esophageal dilatation if any. |