Clinical trial NCT03690804: Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units
Official title: Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn
Keywords: kangaroo care
neonatal intensive care units
autonomic co-regulation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 30
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mother-infant separation, as a result of hospitalization, leads to stress and anxiety for both parent and infant, lowers feelings of maternal competency and corrupts bonding process.

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).


Eligibility criteria: Inclusion Criteria for the newborn :

* Neonates over 28 weeks of gestational age, under 3 months, hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France),
* performing a one hour (or more) kangaroo care session with his parent.

Inclusion Criteria for the parent (father or mother) :

- To be a parent of a child eligible for the research protocol,

Exclusion Criteria for the newborn :

* Newborn sedated
* 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,

Exclusion Criteria for the parents :

* 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

Primary outcomes:
measure: change form baseline high frequency index (HFnu) of variability RR short-term heart rate (HRV) in the frequency domain, from the parent and the child at 1 hour
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
Secondary outcomes:
measure: Evaluation of the NIPE index of comfort and discomfort (Mdoloris Medical Systems ®) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: Evaluation of the ANI index of comfort and discomfort (Mdoloris Medical Systems ®) for the parent.
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: gestational age
timeFrame: at the inclusion
measure: Ptot (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: Ptot (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: VLF (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: VLF (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: LF (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: LF (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: HF (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: HF (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: ratio LF/HF (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: ratio LF/HF (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: SDNN (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: SDNN (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: SDANN (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: SDANN (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: pNN30 and pNN50 (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: pNN30 and pNN50 (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: RMSSD (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: RMSSD (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: SD1 and SD2 (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: SD1 and SD2 (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: Poincaré-plot index (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: Poincaré-plot index (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: fractal index (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: fractal index (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: entropy index (indices of variability of heart rate) for the parent
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
measure: entropy index (indices of variability of heart rate) for the newborn
timeFrame: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: Hugues PATURAL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: