Actively Recruiting

All Genders
ID06760832

Optimizing Enteral Feeding Tube Management in Very Low Birth Weight Preterm Infants Evaluating Intermittent vs. Permanent Gastric Tube Use

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-07

50

Participants Needed

1

Research Sites

336 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to optimize feeding practices for very low-birth-weight (VLBW) premature infants who have reached full enteral feeding. These infants typically need feeding tubes due to difficulty coordinating swallowing, sucking, and breathing until at least 34 weeks of gestational age. The study focuses on comparing different gastric tube management methods, as there is currently no clear evidence on which approach leads to better feeding tolerance and fewer adverse effects. The study evaluates intermittent gastric tube placement versus permanent gastric tube maintenance in VLBW preterm infants fed exclusively with human milk. It also examines the impact of the tube being introduced either orally or nasally. Key factors assessed include gastric stagnation episodes, cardio-respiratory events like desaturation or bradycardia, and signs of pain or discomfort linked to tube insertion and removal during bolus feeding. Participants will be monitored for their tolerance to the different feeding tube management methods. Researchers will record feeding tolerance, adverse effects, and related symptoms during feeding. The study involves close observation of feeding-related events and discomfort to determine the best practices for managing feeding tubes in these vulnerable infants.

CONDITIONS

Official Title

How to Optimize Enteral Feeding of the Full Enteral Feeding Preterm Infant

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age less than 32 weeks and/or neonatal weight less than 1500 grams
  • Full enteral feeding achieved with 150 ml/kg/day of milk
  • Exclusive feeding with human milk (breast milk and/or donor milk)
  • Signed informed consent by parent or legal guardian
Not Eligible

You will not qualify if you...

  • Need for invasive ventilatory support
  • Presence of congenital malformations affecting the gastrointestinal tract

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bolgona, Italy, 40138

Actively Recruiting

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Research Team

A

Arianna Aceti, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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