Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units
NCT ID: NCT03690804
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-09-19
2018-10-25
Brief Summary
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Kangaroo Care (KC), is as a widespread procedure in which the naked newborn is placed on the parent's bare chest. KC is known to enhance neonatal outcome by improving temperature regulation, cardiorespiratory stability or psychomotor development. It also promotes mother-infant interactions and enhances parental psychological well-being.
Heart rate variability (HRV) analysis is a non-invasive tool able to consider autonomic nervous system activity. Previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (HFnu index) reflecting a prevalence of parasympathetic activity. This one can be assess by a new monitor called NIPΣ (Neonatal index of parasympathetic activity) in newborns and ANI (Analgesic nociception index) in adults can provide a comfort index by quantifying the parasympathetic tone.
The investigators hypothesize that kangaroo care could induce an autonomic co-regulation between newborn and parent by increasing parasympathetic activity.
The study will involve 40 preterm or term newborns and their parent, performing a one hour kangaroo care session in intensive unit and neonatal intensive care unit from hospital of Saint-Etienne (France).
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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newborn is above 28 weeks of gestational age
40 parent-newborn duos in which the newborn is above 28 weeks of gestational age and less than 3 months of life and hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France)
Evaluation of Autonomic nervous system indices
The ECG signal, respiration rate, SpO2 and NIPΣ or ANI are recorded simultaneously on a computer with a capture card. The other indices of HRV will be analyzed offline: SDNN (standard deviation of all NN intervals), pNN30 (NN30 count divided by the total number of all NN intervals), pNN50 (NN50 count divided by the total number of all NN intervals), RMSSD (quadratic mean of successive R-R intervals), SD1 (standard deviation), SD2 (standard deviation), LF (low frequencies), HF (high frequencies), VLF (very low frequencies), SDANN (standard deviation of the averages of NN intervals in all 5 min segments of the entire recording), ratio LF/ HF, Ptot, Poincaré plot (plot points corresponding to each R-R space of a record).
Interventions
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Evaluation of Autonomic nervous system indices
The ECG signal, respiration rate, SpO2 and NIPΣ or ANI are recorded simultaneously on a computer with a capture card. The other indices of HRV will be analyzed offline: SDNN (standard deviation of all NN intervals), pNN30 (NN30 count divided by the total number of all NN intervals), pNN50 (NN50 count divided by the total number of all NN intervals), RMSSD (quadratic mean of successive R-R intervals), SD1 (standard deviation), SD2 (standard deviation), LF (low frequencies), HF (high frequencies), VLF (very low frequencies), SDANN (standard deviation of the averages of NN intervals in all 5 min segments of the entire recording), ratio LF/ HF, Ptot, Poincaré plot (plot points corresponding to each R-R space of a record).
Eligibility Criteria
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Inclusion Criteria
* performing a one hour (or more) kangaroo care session with his parent.
\- To be a parent of a child eligible for the research protocol,
Exclusion Criteria
* Newborn with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.
* Associated and severe brain pathology
* Anoxo-ischemic encephalopathy
* Unbalanced congenital heart disease,
* Parent with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.
* Heart surgery or cardiac pathology
* History of psychiatric pathology
3 Months
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Hugues PATURAL, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint Etienne
Locations
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CHU de Saint Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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2018-A00765-50
Identifier Type: OTHER
Identifier Source: secondary_id
18CH048
Identifier Type: -
Identifier Source: org_study_id