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Recruiting Observational

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

NCT06760832 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2020-07-21
Last updated
2025-01-07

Condition(s) studied

Preterm BirthFeeding Methods

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 — 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

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bolgona Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06760832 on ClinicalTrials.gov ↗ ← All trials in Italy