Pilot Study to Evaluate the Benefits of Preterm Newborn Exposition to a Maternal Voice and Heardbeat Recording During Hospital Stay
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Newborn
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Heart rate variability / NIPE Index
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Heart rate variability / NIPE Index
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))
Recorded heart rate
Secondary Outcomes
- 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)))
- Evaluate the benefits for the nurses(To be completed after each use of calinange ether on day 2, 4 and 6)
- Evaluate the benefits for the mother(At day 7, after the end of 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)))
- 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)))