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Clinical Trials/CTRI/2025/11/097060
CTRI/2025/11/097060
Not yet recruiting
Not Applicable

A comparative study of different measuring techniques for appropriate orogastric tube positioning in low birth weight babies

Not provided1 site in 1 country62 target enrollmentStarted: November 16, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
62
Locations
1
Primary Endpoint
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.

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Day(s) to 28.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Time Frame: Baseline

Secondary Outcomes

  • 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)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

CHAITANYA GUPTA

Kasturba Medical College, Manipal

Study Sites (1)

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