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

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).

Study Overview

• Status: Completed
• Conditions: Newborn
• Intervention / Treatment: Device: Evaluation of Autonomic nervous system indices

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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)

Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the NIPE index of comfort and discomfort (Mdoloris Medical Systems ®) for the newborn	NIPΣ (neonatal index of parasympathetic activity) : evaluate the comfort of the newborn during the skin-to-skin session. NIPΣ is physiologically above 60%. The threshold of discomfort in the newborn would correspond to a value <60.	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
Evaluation of the ANI index of comfort and discomfort (Mdoloris Medical Systems ®) for the parent.	ANI (analgesia nociception index) : evaluate an index of continuous analgesia during the skin-to-skin session. ANI is physiologically above 60%. The threshold of discomfort in the newborn would correspond to a value <60.	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
gestational age		at the inclusion
Ptot (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
Ptot (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
VLF (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
VLF (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
LF (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
LF (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
HF (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
HF (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
ratio LF/HF (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
ratio LF/HF (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
SDNN (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
SDNN (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
SDANN (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
SDANN (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
pNN30 and pNN50 (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
pNN30 and pNN50 (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
RMSSD (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
RMSSD (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
SD1 and SD2 (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
SD1 and SD2 (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
Poincaré-plot index (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
Poincaré-plot index (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
fractal index (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
fractal index (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
entropy index (indices of variability of heart rate) for the parent	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
entropy index (indices of variability of heart rate) for the newborn	Measured during the ECG recording	Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Hugues PATURAL, MD PhD, CHU de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: kangaroo care; neonatal intensive care units; autonomic co-regulation
• Other Study ID Numbers: 18CH048; 2018-A00765-50 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No