Ireland
--:--IST
Recruiting Not applicable

Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

NCT07264400 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-10-15
Last updated
2025-12-04

Condition(s) studied

Newborn Infant

Investigational drug(s) / intervention(s)

Heart rate variabilityPulmonary function

Heart rate variability: A Holter ECG recording will be performed on the child's second night for a minimum of 6 hours.

Pulmonary function: Oximetry recording will be performed on the child's second night for a minimum of 6 hours.

Study summary

Ancillary study of the PregMouv study which aims to evaluate an intervention allowing the best adherence of women in terms of physical activity. Several types of interventions are therefore planned in this study: no intervention, physical activity sessions in person, by videoconference or mixed (in person and videoconference) with accelerometer assessment of the level of physical activity practiced (in the form of energy expenditure, in MET). Thus, for our ancillary study, a comparison of the cardiac variability of newborns will be carried out according to the level of physical activity practiced by the mother regardless of the intervention she benefited from within the framework of the PregMouv study. A comparison of the average saturation and the time spent below 90% saturation will be carried out via a continuous recording of saturation by oximetry. A longitudinal follow-up for the assessment of height and weight growth (from growth curves) and neurodevelopment (by clinical examination and self-questionnaire) is also planned until the child is 2 years old.

Eligibility

Sex
ALL
Min age
1 Day
Max age
3 Days
Healthy volunteers
Accepted
Inclusion Criteria: * All newborns of mothers who participated in the PregMouv study and who have at least one piece of data for the main criterion from the PregMouv study (physical activity at T1/T2), * born at the Clermont Ferrand University Hospital and after parental agreement for their child to participate may be included. Exclusion Criteria: * Newborns requiring aminergic support in the first days of life, * making heart rate variability analysis impossible, * having received invasive ventilatory support that does not allow analysis of the oximetry recording. * Parental refusal or inability of parents to give their consent for their child to participate.

Primary outcome measure(s)

  • Heart rate variability — during the child's second night.
    Is measured by SDNN (standard deviation of all normal R-R intervals), a reflection of the variability of the global autonomic nervous system of newborns, obtained from a Holter ECG recording.

Trial sites (1)

FacilityCityRegionStatus
CHU de Clermont-Ferrand Clermont-Ferrand France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07264400 on ClinicalTrials.gov ↗ ← All trials in France