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

NCT03690804 | Completed

• 2 other identifiers: 18CH0482018-A00765-50
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Newborn

Keywords

kangaroo care; neonatal intensive care units; autonomic co-regulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• Evaluation of the NIPE index of comfort and discomfort (Mdoloris Medical Systems ®) for the newborn

  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.

  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

  Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.

• Ptot (indices of variability of heart rate) for the newborn

  Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.

Study Arms (1)

newborn is above 28 weeks of gestational age

EXPERIMENTAL

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

Interventions

Evaluation of Autonomic nervous system indices DEVICE

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).

newborn is above 28 weeks of gestational age

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

Study Officials

• Hugues PATURAL, MD PhD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 1, 2018
• Study Start: September 19, 2018
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)