Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03827252 |
Other study ID # |
PI2017_843_0008 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 7, 2018 |
Est. completion date |
September 12, 2020 |
Study information
Verified date |
May 2023 |
Source |
Centre Hospitalier Universitaire, Amiens |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The main purpose of this study is to identify and to determine the involvement of
cardio-respiratory coordination mechanisms during SSC between the preterm infant and his
(her) parent.
Description:
The skin to skin care (SSC) is a technique that proceeds by laying the neonate ventrally on
the parent's chest. Many positive effects are recognized as due to SSC i.e, maintaining the
infant's body temperature, better sleep organization, neurocognitive development and
cardio-respiratory stability, more strength in parent-infant affective relations, reduction
in neonatal and parental stress, more success in feeding with breast milk. Nowadays, SSC is
generalized in modern Neonatal Intensive Care Units as part of developmental care. However,
the mechanisms involved in SSC are not totally understood. The hypothesis in this study is
that the cardio-respiratory stability results partially from the intervention of the
coordination between cardiac and respiratory activities. These suppose the involvement of
complex mechanisms of cardio-respiratory coordination including neuro-autonomous loops with
chemoreceptors and baroreceptors, bulbar vasomotor and respiratory regulatory centers,
ortho-parasympathetic neuronal and chemical pathways and cardiac, vascular and lung
effectors. In this study the identification of these characteristics will be performed by
processing signals of ECG, SaO2 (arterial oxygen saturation), respiratory movements,
perfusion index, cutaneous and ambient temperature extracted from the clinical monitoring
systems. Each preterm infant included in the study will be explored twice, 5-10 days apart.
The explorations will be carried out on 3 steps: before (at least 30 minutes), during (at
least 60 minutes) and after (≥ 60 minutes) the SSC session. Each patient will participate in
the study for 10 days at maximum. Inclusions in the study will last for a total period of 18
months and 10 days. The cardio-respiratory coordination will be assessed using coordigram
technique, corresponding to the proportion of time with > 0.7 amplitude on spectral density.