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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-19

Study Completion Date

2023-04-30

Brief Summary

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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.

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Detailed Description

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Immediately after birth, preterm newborns are immersed in a hostile environment of intensive care unit with light, sound and painful stimulations. Previously, exposure to maternal voice has demonstrated improvement on infants' statements: reduction of bradycardia, desaturation events, improvement of tolerance feeding and sleep. Unfortunatly in most of the N ICU in France, the mothers' presence attendance time is reduced because of the absence of accommodation structure. The use of a specific neonatal device able to daily record maternal voice and hearbeats and to restore it when mother is gone could improve the environment and promote the well-being of the newborn.

Conditions

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Preterm Newborn

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Calinage exposition

exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D2, D4 and D6

Group Type EXPERIMENTAL

calinange

Intervention Type DEVICE

calinange

no exposition

No exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D1, D3 and D5

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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calinange

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* hospitalised premature newborn in Port-Royal NICU
* age between 3 and 6 daysof life
* gestational age between 27+0 and 31+6 weeks
* hospitalisation in one bed room
* parental consents
* beneficiaries social security scheme

* Chromosomal abnormality, severe congenital malformation
* Toxic substance consumption during pregnancy
* Sedative medication in progress, High frequencies ventilation in progress
* Neurological damage: intraventricular haemorrhage stage 3 and 4, bilateral and expanse periventricular leukomalacia lesions
* Severe infectious state requiring haemodynamic support (inotropic drugs or hemissucinate)
* Participation to a other intervention research

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No