Status:
UNKNOWN
Efficacy Study of a Device Allowing Broadcasting Maternal Voice and Heartbeat in Preterm Newborn (CALIPREM)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Preterm Newborn
Eligibility:
All Genders
Up to 7 years
Phase:
NA
Brief 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 de...
Detailed 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 demonstrat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04757012
Start Date
April 19 2022
End Date
April 1 2023
Last Update
September 28 2022
Active Locations (1)
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1
NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital
Paris, France, 75014