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

NCT06760832 | Recruiting

• 1 other identifier: NE_PRE_20
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Birth; Feeding Methods

Keywords

enteral feeding; preterm newborns; full enteral feeding

Outcome Measures

Primary Outcomes (1)

• 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

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

  From the 1st patient enrolled, up to 50th patient enrolled

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of all preterm infants of gestational age \<32 weeks and/or neonatal weight \<1500 g born at sant'orsola hospital. Based on birth data of preterm infants with these characteristics, it is estimated that within one year, approximately 50 infants will be enrolled

You may qualify if:

• 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

You may not qualify if:

• Need for invasive ventilatory support
• Congenital malformations affecting the gastrointestinal tract

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bolgona, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Arianna Aceti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arianna Aceti, MD

CONTACT

0512143779; arianna.aceti2@unibo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 7, 2025
• Study Start: July 21, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-12

Locations

IT (1)