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

Assistance Publique - Hôpitaux de Paris30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Preterm Newborn

Interventions

calinangeDEVICE

calinange

Eligibility

Sex: ALLMax age: 7 Days

Medical Language ↔ Plain English

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

Locations (1)

NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital

Paris, France

Outcomes

Primary Outcomes

Heart rate variability / NIPE Index

Recorded heart rate

Time frame: Change of the NIPE index before and after intervention. Each baby is his own control. Nipe index is recorded 10 minutes before and 10 minutes after the intervention (Calinange (day 2/4/6) or nothing (day 1/3/5))

Secondary Outcomes

Number of desaturation events

Change in desaturation events before and after intervention

Number of apnoeic events

Change in apneic events before and after intervention

Number of bradycardia events

Change in bradycardia events before and after intervention

Evaluate the benefits for the nurses

Evaluation questionnaire

Time frame: To be completed after each use of calinange ether on day 2, 4 and 6

Evaluate the benefits for the mother

Satisfaction questionnaire

Time frame: At day 7, after the end of intervention

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.