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

Not Applicable

Recruiting

• Conditions: Preterm Newborn
• Interventions: Device: calinange

• Registration Number: NCT04757012
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 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.

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 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 Timeline

• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-16
• Study Start: 2022-04-19
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28
• Primary Completion: 2023-01
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Calinage exposition	calinange	exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D2, D4 and D6

Primary Outcome Measures

Name	Time	Method
Heart rate variability / NIPE Index	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))	Recorded heart rate

Secondary Outcome Measures

Name	Time	Method
Number of desaturation events	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))	Change in desaturation events before and after intervention
Evaluate the benefits for the nurses	To be completed after each use of calinange ether on day 2, 4 and 6	Evaluation questionnaire
Evaluate the benefits for the mother	At day 7, after the end of intervention	Satisfaction questionnaire
Number of bradycardia events	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))	Change in bradycardia events before and after intervention
Number of apnoeic events	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))	Change in apneic events before and after intervention

Trial Locations

Locations (1)

NICU of Port-Royal, Maternity of Port-Royal, Cochin Hospital; 🇫🇷 Paris, France