Pilot Study to Evaluate the Benefits of Preterm Newborn Exposition to a Maternal Voice and Heardbeat Recording During Hospital Stay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Heart rate variability / NIPE Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
no exposition
No exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D1, D3 and D5
Calinage exposition
exposition to a maternal voice and heartbeat recording during hospital stay for preterm newborns at D2, D4 and D6
干预措施: calinange (Device)
结局指标
主要结局
Heart rate variability / NIPE Index
时间窗: 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
次要结局
- 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)))