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Effects of a Valved Feeding System in Late-preterm Newborns: the Safe Oral Feeding Trial

NCT04400175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-21

No results posted yet for this study

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.

Conditions

  • Premature Birth
  • Feeding; Difficult, Newborn
  • Feeding, Bottle

Interventions

DEVICE

Valved ergonomic teat

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

DEVICE

Standard silicon teat

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

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Francesco Cresi, MD; PhD · Città della Salute e della Scienza - Ospedale S.Anna - University of Turin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04400175 on ClinicalTrials.gov