Correct Gastric Tube Placement in Very Low Birth Weight Neonates

Correct Gastric Tube Placement in Very Low Birth Weight Neonates: Comparison of NEX and NEMU Methods

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.

Study Overview

• Status: Completed
• Conditions: Gastric Tube Placement
• Intervention / Treatment: Device: oro gastric tube

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 Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20100
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Mangiagalli Regina Elena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

VLBW infants

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NEX group; oro gastric tube placement using NEX insertion length predictor	Device: oro gastric tube; According to clinical need, an orogastric tube will be inserted at birth using the group method in VLBW infants in whom an umbilical catheter has been placed. An X-ray chest will be performed according to routine clinical practice to assess the position of the umbilical catheter. On the same X-ray the position of the gastric tube will be assessed by a radiologist blinded to the method used for orogastric tube placement.
NEMU group; oro gastric tube placement using NEMU insertion length predictor	Device: oro gastric tube; According to clinical need, an orogastric tube will be inserted at birth using the group method in VLBW infants in whom an umbilical catheter has been placed. An X-ray chest will be performed according to routine clinical practice to assess the position of the umbilical catheter. On the same X-ray the position of the gastric tube will be assessed by a radiologist blinded to the method used for orogastric tube placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric tube position	Control on X-ray chest of the gastric tube placement by NEX and NEMU methods	within 24 hours

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: Chiara Baracetti, RN, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Mangiagalli Regina Elena, Milano (ITALY)

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2015
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: July 14, 2019
• First Submitted That Met QC Criteria: October 13, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Nursing; Prematurity; Enteral nutrition; Gastric tube; VLBW - Very Low Birth Weight Infant
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: GT PLACEMENT IN VLBW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No