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Efficacy Study of a Device Allowing Broadcasting Maternal Voice and Heartbeat in Preterm Newborn (CALIPREM)

NCT04757012 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-09-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the benefits of an exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns. For that, we use of a specific neonatal device "Calinange" able to record maternal voice and heartbeats and to restore it with a sound level control. We hypothesize an improvement of the well being of the newborn under Calinange exposition.

Conditions

  • Preterm Newborn

Interventions

DEVICE

calinange

calinange

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Juliana PATKAI, MD · Service de Médecine et Réanimation néonatales de Port-Royal APHP.Centre - Université de Paris. Site Cochin.

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-01-31
Completion
2023-04-30

Countries

  • France

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 NCT04757012 on ClinicalTrials.gov