Correct Gastric Tube Placement in Very Low Birth Weight Neonates

Study Overview
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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.

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

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

Conditions
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Gastric Tube Placement

Intervention / Treatment
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* Device: oro gastric tube


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NEX group<br>oro gastric tube placement using NEX insertion length predictor | Device: oro gastric tube<br>* 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.<br>|
| NEMU group<br>oro gastric tube placement using NEMU insertion length predictor | Device: oro gastric tube<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric tube, VLBW - Very Low Birth Weight Infant, Enteral nutrition, Prematurity, Nursing