Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Heart rate variability

    Other intervention

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

  • Pulmonary function

    Other intervention

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Assessment of cardiorespiratory functionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
during the child's second night.

Secondary outcomes

1

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)

Time frame
during the child's second night
2

Heart rate variability

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

Time frame
during the child's second night
3

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)

Time frame
during the child's second night
4

Heart rate variability

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

Time frame
during the child's second night

Other outcomes

Sponsors and contacts

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