Correct Gastric Tube Placement in Very Low Birth Weight Neonates

Completed

• Conditions: Gastric Tube Placement
• Interventions: Device: oro gastric tube

• Registration Number: NCT04127773
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

Gastric tube (GT) placement is a recurrent procedure in VLBW infants due to feeding impairment correlated with low birth weight.

Correct GT depth is mandatory to ensure an appropriate and safe enteral feeding: X-ray is the gold standard in order to check GT position, but this cannot be routinely performed due to x-ray exposure risk. Feeding a neonate through a misplaced GT is potentially harmful and may increase morbidity, mortality and hospitalization length.

Nurses estimate GT depth through external measurements. This study aims to identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing two different methods.

Detailed Description

Several methods have been suggested to estimate orogastric tube insertion length, but none of them has been validated in VLBW infants. The most commonly used methods are NEX (Nose-Ear-Xyphoid) and NEMU (Nose-Ear-Mid-Umbilicus) as predictors of nasogastric tube insertion. For the purpose of the present study NEX and NEMU methods were adjusted for orogastric tube placement.

Hence, primary aim of this study is:

To identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing NEX and NEMU methods.

Secondary aim is:

- To develop a new mathematical formula, based on the neonate's weight or length, to predict the insertion length of orogastric tube in VLBW infants

Study Timeline

• Study Start: 2015-03-06
• Study First Submitted: 2019-07-14
• Study First Submitted QC: 2019-10-13
• Study First Posted: 2019-10-16
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Birth Weight ≤1500 grams (Very Low Birth Weight Infants)
• Need for both umbilical catheter and gastric tube positioning at birth

Exclusion Criteria

• Birth Weight >1500 grams
• Congenital respiratory or gastrointestinal tract malformations (from oral cavity to stomach included)
• Critically unstable preterm infants will be excluded according to nurse or physician evaluation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NEX group	oro gastric tube	oro gastric tube placement using NEX insertion length predictor
NEMU group	oro gastric tube	oro gastric tube placement using NEMU insertion length predictor

Primary Outcome Measures

Name	Time	Method
Gastric tube position	within 24 hours	Control on X-ray chest of the gastric tube placement by NEX and NEMU methods

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Mangiagalli Regina Elena; 🇮🇹 Milan, Italy