Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2029-04-30

Brief Summary

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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.

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Detailed Description

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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

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Newborn Infant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Assessment of cardiorespiratory function

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.

Group Type EXPERIMENTAL

Heart rate variability

Intervention Type OTHER

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

Pulmonary function

Intervention Type OTHER

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

Interventions

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Heart rate variability

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

Intervention Type OTHER

Pulmonary function

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes