Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
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 NIPĪ£ (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).
Study:
NCT03690804
Study Brief:
Protocol Section:
NCT03690804