Correct Gastric Tube Placement in Very Low Birth Weight Neonates

Gastric Tube Placement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04127773
• Other study ID #: GT PLACEMENT IN VLBW
• Status: Completed
• Start date: March 6, 2015
• Est. completion date: April 2020

Study information

• Verified date: February 2021
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Gastric Tube Placement

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Mangiagalli Regina Elena	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric tube position	Control on X-ray chest of the gastric tube placement by NEX and NEMU methods	within 24 hours