Clinical Trials Directory

Trials / Completed

CompletedNCT04127773

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

Status
Completed
Phase
Study type
Observational
Enrollment
220 (actual)
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
Sex
All
Age
0 Days – 28 Days
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DEVICEoro gastric tubeAccording 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.

Timeline

Start date
2015-03-06
Primary completion
2020-04-01
Completion
2020-04-01
First posted
2019-10-16
Last updated
2021-02-15

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04127773. Inclusion in this directory is not an endorsement.