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

Study Overview
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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.

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.

Official Title
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Pilot Study to Evaluate the Benefits of Preterm Newborn Exposition to a Maternal Voice and Heardbeat Recording During Hospital Stay

Conditions
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Preterm Newborn

Intervention / Treatment
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* Device: calinange


Participation Criteria
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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 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

Ages Eligible for Study
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Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calinage exposition<br>exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D2, D4 and D6 | Device: calinange<br>* calinange<br>|
| No Intervention: no exposition<br>No exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D1, D3 and D5 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability / NIPE Index | Recorded heart rate | 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm newborn, Maternal voice reccording, NIPE