CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 280 enrolled
Drug / intervention
HHHFNC +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03548324
NCT03548324N/ACompleted

Enteral Nutrition Tolerance and Non-invasive Respiratory Support in Preterm Infants

University of Turin, Italy·interventional·Posted Jun 7, 2018·Updated Aug 23, 2022

In Brief

A clinical study evaluating HHHFNC and NCPAP for Very Low Birth Weight Infant and 2 related conditions. Completed, enrolled 280 participants across 13 sites.

Detailed Summary

This research study aims to evaluate the relation between non-invasive ventilation and feeding tolerance in preterms with respiratory distress syndrome (RDS). To this purpose a multicenter randomized controlled trial was designed. It will involve 13 neonatal intensive care units (NICUs) in Italy and will be coordinated by the NICU of the University of Turin. The study focuses on the impact of two non-invasive respiratory support techniques (NCPAP and HHHFNC) on feeding intolerance and gastrointestinal complications to identify which technique is the most effective and safe in preterms with RDS. Further aim is to identify which technique could be the most suitable for full enteral feeding achievement and acquisition of oral feeding. Improving enteral feeding tolerance and promoting oral feeding could improve clinical outcomes and reduce risks and costs of prolonged hospital stay. Further aim is to evaluate the response to NCPAP and HHHFNC in the treatment of RDS, focusing on a population of extremely low preterms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 7, 2018
Enrollment StartJan 2, 2019
Primary CompletionSep 30, 2021
Study CompletionOct 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.1 years ago

Interventions

HHHFNCdevice

Application to HHHFNC to treat respiratory distress syndrome in preterm infants previously demonstrated to be stable on a non-invasive respiratory support (HHHFNC or NCPAP).

NCPAPdevice

Application to NCPAP to treat respiratory distress syndrome in preterm infants previously demonstrated to be stable on a non-invasive respiratory support (HHHFNC or NCPAP).