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CTRI Number  CTRI/2025/11/097060 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 05/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To determine most appropriate method of predicting oral tube position in neonates aiming to decrease malpositioned tubes in low birth weight babies admitted in NICU 
Scientific Title of Study   A comparative study of different measuring techniques for appropriate orogastric tube positioning in low birth weight babies 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHAITANYA GUPTA 
Designation  JUNIOR RESIDENT 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Paediatrics, Kasturba Medical College, Madhav Nagar, Manipal 576104, Udupi - 576104, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9569414003  
Fax    
Email  guptachaitanya786@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Leslie Edward S Lewis 
Designation  Professor and head of unit 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Paediatrics, KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  9449208476  
Fax    
Email  leslie.lewis@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Leslie Edward S Lewis 
Designation  Professor and head of unit 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Paediatrics, KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  9449208476  
Fax    
Email  leslie.lewis@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal 
NIL 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chaitanya Gupta  Kasturba Medical College and Hospital  Department of Paediatrics Udupi KARNATAKA
Udupi
KARNATAKA 		 9569414003

guptachaitanya786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - 2   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P071||Other low birth weight newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  1 All neonates weighing less than 2.5 kg admitted in NICU, KMC Manipal.
2 Neonates with OG tubes in place using the NEMU method
3 A confirmation chest CXray done after the placement of tube (only when clinically
indicated) 
 
ExclusionCriteria 
Details  1 Neonates with a congenital malformation in the gastrointestinal tract, skeletal
abnormality involving the neck and thoracic vertebral column.
2 Congenital anomalies/edema of face/Dysmorphic or syndromic neonates.
3 If proper position of the gastric tube could not be visualized on the CX Ray.
4 Stable neonates for which CXRay is not indicated clinically 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine most appropriate method of predicting orogastric tube position in neonates aiming to decrease malpositioned tubes in low birth weight babies admitted in NICU.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1 To determine the variations in accuracy of different methods in LBW babies, VLBW babies and ELBW babies
2 To compare a novel method of combining birth-weight based formula in conjunction with NEMU method with other methods of orogastric tube placement in ELBW neonates 		 Baseline 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   16/11/2025 
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 Applicable 
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  

This prospective observational comparative cohort study aims to identify the most accurate method for predicting appropriate orogastric tube placement in low birth weight neonates admitted to the NICU at Kasturba Hospital, Manipal. Orogastric tubes are commonly used in newborns for feeding and gastric decompression, but incorrect placement can cause serious respiratory and gastrointestinal complications. The study compares different measurement techniques, including the standard NEMU method, a weight-based formula, and a combined method in extremely low birth weight babies. All eligible neonates under 2.5 kg will be included, and tube positions will be confirmed through clinically indicated chest X-rays. The accuracy of each method will be evaluated based on radiographic findings and categorized as proper, high, or deep placement. The study will help determine the most reliable and safe method to reduce malpositioned tubes and improve clinical outcomes in vulnerable neonates.

 
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