NCT07264400

Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Accepted

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.

Detailed description

Holter ECG and oximetry recording of the newborn for a minimum of 6 hours during their stay in the maternity ward, or in another perinatal sector. Evaluation at the child's 2nd birthday by collecting the height-weight curve, the 2nd birthday clinical examination and self-questionnaire, ASQ, from the parents. Blind interpretation and analysis of the results. Comparison of the results according to the mothers' level of physical activity (in MET/min/week), assessed by the accelerometer study at T2 and T3 of pregnancy. Search for correlation between the level of physical activity practiced and the child's physiological parameters.

Conditions

• Newborn Infant

Interventions

Type	Name	Description
OTHER	Heart rate variability	A Holter ECG recording will be performed on the child's second night for a minimum of 6 hours.
OTHER	Pulmonary function	Oximetry recording will be performed on the child's second night for a minimum of 6 hours.

Timeline

• Start date: 2025-10-15
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: France