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Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07264400
Acronym
NEOMOUV
Enrollment
100
Registered
2025-12-04
Start date
2025-10-15
Completion date
2029-04-30
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Infant

Keywords

heart rate variability, oximetry

Brief 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.

Interventions

OTHERHeart rate variability

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

OTHERPulmonary function

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

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variabilityduring the child's second night.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.

Secondary

MeasureTime frameDescription
Heart rate variabilityduring the child's second nightOthers parameters of heart rate variabilt obtained from a Holter ECG recording by RMSSD (root mean square of differences of successive RR intervals)
Respiratory functionDuring the child's second nightAssessed by oximetry: desaturation index and drop per hour of more than 3%.
Height growthat 2 years oldheight measurement in centimeters
weight growthat 2 years oldweight measurement in kilograms
neurodevelopmentat 24 monthsassessed by the Ages & Stages Questionnaires, Third Edition (ASQ-3)

Countries

France

Contacts

Primary ContactLise Laclautre
promo_interne_drci@chu-clermontferrand.fr+33473754963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026