Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07264400

Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Newborn Infant

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location status: Recruiting

Location contact

Justine PAYSAL

PRINCIPAL_INVESTIGATOR

Lise Laclautre

CONTACT

[email protected]

+33473754963

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heart Rate Variability

Other

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

Pulmonary Function

Other

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

Primary outcomes

  1. Heart rate variability

    Time frame: during 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 outcomes

  1. Heart rate variability

    Time frame: during the child's second night

    Others parameters of heart rate variabilt obtained from a Holter ECG recording by RMSSD (root mean square of differences of successive RR intervals)

  2. Heart rate variability

    Time frame: during the child's second night

    Others parameters of heart rate variabilt obtained from a Holter ECG recording by NN50 (number of RR intervals that differ by > 50 ms)

  3. Heart rate variability

    Time frame: during the child's second night

    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)

  4. Heart rate variability

    Time frame: during the child's second night

    Others parameters of heart rate variabilt obtained from a Holter ECG recording by SD1 (standard deviation 1)

  5. Heart rate variability

    Time frame: during the child's second night

    Others parameters of heart rate variabilt obtained from a Holter ECG recording by and HF (high frequency power)

  6. Heart rate variability

    Time frame: during the child's second night

    Others parameters of heart rate variabilt obtained from a Holter ECG recording by SD2 (standard deviation 2)

  7. Heart rate variability

    Time frame: during the child's second night

    Others parameters of heart rate variabilt obtained from a Holter ECG recording by SD1/SD2 ratio

  8. Heart rate variability

    Time frame: during the child's second night

    Others parameters of heart rate variabilt obtained from a Holter ECG recording by LF (low frequency)

  9. Respiratory function

    Time frame: During the child's second night

    Assessed by oximetry: desaturation index and drop per hour of more than 3%.

  10. Respiratory function

    Time frame: During the child's second night

    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)

  11. Respiratory function

    Time frame: During the child's second night

    Assessed by oximetry: mean saturation (in raw value and in two classes depending on whether the value is strictly less than 93)

  12. Height growth

    Time frame: at 2 years old

    height measurement in centimeters

  13. weight growth

    Time frame: at 2 years old

    weight measurement in kilograms

  14. neurodevelopment

    Time frame: at 24 months

    assessed by the Ages & Stages Questionnaires, Third Edition (ASQ-3)

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: NEOMOUV

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.