NCT06760832 How to Optimize Enteral Feeding of the Full Enteral Feeding Preterm Infant
| NCT ID | NCT06760832 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Preterm Birth |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-07-21 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2020-07-21 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Arianna Aceti, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06760832 clinical trial?
This trial is open to participants of all sexes, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06760832 currently recruiting?
Yes, NCT06760832 is actively recruiting participants. Contact the research team at arianna.aceti2@unibo.it for enrollment information.
Where is the NCT06760832 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06760832 clinical trial?
NCT06760832 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Arianna Aceti, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 50 participants.