Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Heart rate variability, Pulmonary function.
- Who it may be relevant to
- Registry conditions: Newborn Infant. Basic parameters: 1 Day — 3 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Heart rate variability [Time frame: during the child's second night.]
Secondary outcome measures (12)
- Heart rate variability [Time frame: during the child's second night]
- Heart rate variability [Time frame: during the child's second night]
- Heart rate variability [Time frame: during the child's second night]
- Heart rate variability [Time frame: during the child's second night]
- Heart rate variability [Time frame: during the child's second night]
- Heart rate variability [Time frame: during the child's second night]
- Heart rate variability [Time frame: during the child's second night]
- Heart rate variability [Time frame: during the child's second night]
- Respiratory function [Time frame: During the child's second night]
- Respiratory function [Time frame: During the child's second night]
- Respiratory function [Time frame: During the child's second night]
- Height growth [Time frame: at 2 years old]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- CHU de Clermont-Ferrand — Clermont-Ferrand
Identifiers
NCT: NCT07264400 · RBHP 2025 PAYSAL · 2025-A00329-40