Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00329-40 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessment of cardiorespiratory function | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart rate variability | Other | A Holter ECG recording will be performed on the child's second night for a minimum of 6 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | 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. | during the child's second night. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | Others parameters of heart rate variabilt obtained from a Holter ECG recording by RMSSD (root mean square of differences of successive RR intervals) | during the child's second night |
| Heart rate variability |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | +33473754963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Justine Paysal | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pulmonary function | Other | Oximetry recording will be performed on the child's second night for a minimum of 6 hours. |
|
Others parameters of heart rate variabilt obtained from a Holter ECG recording by NN50 (number of RR intervals that differ by > 50 ms)
| during the child's second night |
| Heart rate variability | Others parameters of heart rate variabilt obtained from a Holter ECG recording by p NN50 (percentage of consecutive RR intervals that differ by >50 ms) | during the child's second night |
| Heart rate variability | Others parameters of heart rate variabilt obtained from a Holter ECG recording by SD1 (standard deviation 1) | during the child's second night |
| Heart rate variability | Others parameters of heart rate variabilt obtained from a Holter ECG recording by and HF (high frequency power) | during the child's second night |
| Heart rate variability | Others parameters of heart rate variabilt obtained from a Holter ECG recording by SD2 (standard deviation 2) | during the child's second night |
| Heart rate variability | Others parameters of heart rate variabilt obtained from a Holter ECG recording by SD1/SD2 ratio | during the child's second night |
| Heart rate variability | Others parameters of heart rate variabilt obtained from a Holter ECG recording by LF (low frequency) | during the child's second night |
| Respiratory function | Assessed by oximetry: desaturation index and drop per hour of more than 3%. | During the child's second night |
| Respiratory function | Assessed by oximetry: time spent below 90%, 80% and 70% saturation (in raw value and in two classes depending on whether the value is greater than or equal to 5) | During the child's second night |
| Respiratory function | Assessed by oximetry: mean saturation (in raw value and in two classes depending on whether the value is strictly less than 93) | During the child's second night |
| Height growth | height measurement in centimeters | at 2 years old |
| weight growth | weight measurement in kilograms | at 2 years old |
| neurodevelopment | assessed by the Ages & Stages Questionnaires, Third Edition (ASQ-3) | at 24 months |