Preterm Newborn
Conditions
Keywords
Preterm newborn, Maternal voice reccording, NIPE
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.
Interventions
DEVICEcalinange
calinange
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJuliana PATKAI, MD
Service de Médecine et Réanimation néonatales de Port-Royal APHP.Centre - Université de Paris. Site Cochin.
Outcome results
None listed