CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Valved ergonomic teat +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/NCT04400175
NCT04400175N/ACompleted
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Effects on Coordination of Sucking, Swallowing and Breathing Process of a Valved Feeding System in Late-preterm Newborns. The Safe Oral Feeding Trial (SOFT)

University of Turin, Italy·interventional·Posted May 22, 2020·Updated Aug 21, 2023

In Brief

A clinical study evaluating Valved ergonomic teat and Standard silicon teat for Premature Birth and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Comparing with a randomized controlled trial two different feeding systems in two groups of late-preterm newborns for evaluating which is more efficient in promoting the coordination in the process of sucking-swallowing-breathing and better cardiorespiratory stability. The B-ESP group will be fed with a feeding system with a valved ergonomic teat; the B-STD with a standard feeding system.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Birth, Feeding; Difficult, Newborn, Feeding, Bottle
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 22, 2020
Enrollment StartDec 1, 2020
Primary CompletionMay 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.1 years ago

Interventions

Valved ergonomic teatdevice

Administration of milk with a feeding system with a valved ergonomic teat in late preterm newborns.

Standard silicon teatdevice

Administration of milk with a feeding system with a standard silicon teat