Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns (NEOMOUV)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Newborn Infant

Treatments: Other: Pulmonary function; Other: Heart rate variability

Study type: Interventional

Funder types: Other

Identifiers

NCT07264400

RBHP 2025 PAYSAL

2025-A00329-40 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 3 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Assessment of cardiorespiratory function

Experimental group

Description:

A Holter ECG and oximetry recording will be performed on the child's second night for a minimum of 6 hours. Three electrodes will be placed on the newborn's chest, along with a pulse oximeter, and removed the following day. Parents will be contacted by email at the child's second birthday to obtain information on their child's height and weight growth, and their neurodevelopment will be assessed using the Age and Stage Questionnaire (ASQ-3) at 24 months.

Treatment:

Other: Heart rate variability

Other: Pulmonary function