Correct Gastric Tube Placement in Very Low Birth Weight Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-06

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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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

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Gastric Tube Placement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NEX group

oro gastric tube placement using NEX insertion length predictor

oro gastric tube

Intervention Type DEVICE

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

oro gastric tube

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

0 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No