Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units (Co-PAP)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Newborn

Treatments: Device: Evaluation of Autonomic nervous system indices

Study type: Interventional

Funder types: Other

Identifiers

NCT03690804

18CH048

2018-A00765-50 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

newborn is above 28 weeks of gestational age

Experimental group

Description:

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)

Treatment:

Device: Evaluation of Autonomic nervous system indices