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

Very low-birth-weight premature infants (VLBWs) are fed via nasal or oro-gastric tube for a long time because of the physiological inability to coordinate swallowing, sucking, and breathing until at least 34 weeks of gestational age.

Both bolus and continuous feeding modes are widely described in the literature; both modes have specific risks and benefits, and there is no evidence in the literature as to which mode is best in terms of tolerance and adverse effects.

To date, the characteristics of enteral feeding that are associated with better feeding tolerance and fewer adverse effects have not been uniquely documented.

There are currently no data in the literature directly comparing different modes of enteral feeding tube management in the preterm VLBW infant. Therefore, our study aims to evaluate different modes of enteral feeding tube management (extemporaneous vs. permanent introduction/removal and oral vs. nasal introduction route) in order to optimize enteral feeding management of the VLBW infant.

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Key information

Conditions

Preterm Birth Feeding Methods Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bolgona, 40138, Italy

Location status: Recruiting

About this study

The purpose of the study is to evaluate the tolerance of intermittent gastric tube placement versus permanent gastric tube maintenance in preterm VLBW infants who have achieved full enteral feeding, and to record the incidence of adverse effects associated with the different modes of gastric tube management.

Specifically, during bolus feeding, the following parameters will be evaluated in association with the two different management modes:

Presence, extent and characteristics of episodes of gastric stagnation
Incidence of cardio-respiratory events (desaturation and/or bradycardia)
Signs and symptoms of pain/discomfort related to the tube insertion and removal procedure In addition, the above parameters will be examined during enteral feeding with an orally or nasally introduced tube.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Gestational Age <32 weeks and/or neonatal weight <1500 g
Achievement of full enteral feeding (150 ml/kg/day of milk)
Exclusive feeding of human milk (breast and/or bank)
Informed consent signed by parent or legal guardian

Exclusion criteria

Need for invasive ventilatory support
Congenital malformations affecting the gastrointestinal tract

Treatment and study plan

Primary outcomes

Evaluate the tolerance to intermittent gastric tube placement versus permanent gastric tube maintenance in Very Low Birth Weight preterm infants who have achieved full enteral feeding

Time frame: From the 1st patient enrolled, up to 50th patient enrolled

tolerance of intermittent gastric tube placement versus permanent gastric tube maintenance in preterm VLBW infants

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

How to Optimize Enteral Feeding of the Full Enteral Feeding Preterm Infant: Evaluation of Different Gastric Tube Management Practices

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2026
First posted: Jan 7, 2025
Registry last updated: Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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