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Completed

NCT Number: NCT03690804

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

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).

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Key information

Conditions

Newborn

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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

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

    Measured during the ECG recording

Secondary outcomes

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

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

    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.

  2. Evaluation of the ANI index of comfort and discomfort (Mdoloris Medical Systems ®) for the parent.

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

    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.

  3. gestational age

    Time frame: at the inclusion

  4. Ptot (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  5. Ptot (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  6. VLF (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  7. VLF (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  8. LF (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  9. LF (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  10. HF (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  11. HF (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  12. ratio LF/HF (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  13. ratio LF/HF (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  14. SDNN (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  15. SDNN (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  16. SDANN (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  17. SDANN (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  18. pNN30 and pNN50 (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  19. pNN30 and pNN50 (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  20. RMSSD (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  21. RMSSD (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  22. SD1 and SD2 (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  23. SD1 and SD2 (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  24. Poincaré-plot index (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  25. Poincaré-plot index (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  26. fractal index (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  27. fractal index (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

  28. entropy index (indices of variability of heart rate) for the parent

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

    Measured during the ECG recording

  29. entropy index (indices of variability of heart rate) for the newborn

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

    Measured during the ECG recording

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: Co-PAP

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2018
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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