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

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Preterm Newborn

Treatments

Device: calinange

Study type

Interventional

Funder types

Other

Identifiers

NCT04757012

2020-A01369-30 (Other Identifier)

En cours

Details and patient eligibility

About

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.

Full description

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.

Enrollment

32 estimated patients

Sex

All

Ages

Under 7 days old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria

occurrence of one or more non-inclusion criteria
Non-inclusion Criteria:
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