Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units
- Conditions
- Newborn
- Interventions
- Device: Evaluation of Autonomic nervous system indices
- Registration Number
- NCT03690804
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description newborn is above 28 weeks of gestational age Evaluation of Autonomic nervous system indices 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)
- Primary Outcome Measures
Name Time Method 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 Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
- Secondary Outcome Measures
Name Time Method 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. 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.Ptot (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
VLF (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
ratio LF/HF (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
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. Measured during the ECG recording
SDANN (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
SD1 and SD2 (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
fractal index (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
VLF (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
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. 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.LF (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
HF (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
HF (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
ratio LF/HF (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
SDNN (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
SDNN (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
pNN30 and pNN50 (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
pNN30 and pNN50 (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
LF (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
SDANN (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
RMSSD (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
RMSSD (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
SD1 and SD2 (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
Poincaré-plot index (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
Poincaré-plot index (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
fractal index (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
entropy index (indices of variability of heart rate) for the parent Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
entropy index (indices of variability of heart rate) for the newborn Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60. Measured during the ECG recording
Trial Locations
- Locations (1)
CHU de Saint Etienne
🇫🇷Saint-Étienne, France