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

NCT03690804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-10-31

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Hugues PATURAL, MD PhD · CHU de Saint Etienne

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2018-10-25
Completion
2018-10-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690804 on ClinicalTrials.gov