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Correct Gastric Tube Placement in Very Low Birth Weight Neonates

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

Gastric Tube Placement

Treatments

Device: oro gastric tube

Study type

Observational

Funder types

Other

Identifiers

NCT04127773
GT PLACEMENT IN VLBW

Details and patient eligibility

About

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.

Full 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

Enrollment

220 patients

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

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

Trial design

220 participants in 2 patient groups

NEX group
Description:
oro gastric tube placement using NEX insertion length predictor
Treatment:
Device: oro gastric tube
NEMU group
Description:
oro gastric tube placement using NEMU insertion length predictor
Treatment:
Device: oro gastric tube

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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