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

Newborn Clinical Trial

— Co-PAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690804
• Other study ID #: 18CH048
• Secondary ID: 2018-A00765-50
• Status: Completed
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: October 25, 2018

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Newborn

Intervention

Device:
• Evaluation of Autonomic nervous system indices
The ECG signal, respiration rate, SpO2 and NIPS 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).

Locations

Country	Name	City	State
France	CHU de Saint Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of the NIPE index of comfort and discomfort (Mdoloris Medical Systems ®) for the newborn	NIPS (neonatal index of parasympathetic activity) : evaluate the comfort of the newborn during the skin-to-skin session.; NIPS 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.
Secondary	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.
Secondary	gestational age		at the inclusion
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.