Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns

NCT07264400 | Recruiting

• 2 other identifiers: RBHP 2025 PAYSAL2025-A00329-40
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn Infant

Keywords

heart rate variability; oximetry

Outcome Measures

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.

  during the child's second night.

Secondary Outcomes (14)

• Heart rate variability

  during the child's second night

• Heart rate variability

  during the child's second night

• Heart rate variability

  during the child's second night

• Heart rate variability

  during the child's second night

• Heart rate variability

  during the child's second night

Study Arms (1)

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.

Other: Heart rate variability; Other: Pulmonary function

Interventions

Heart rate variability OTHER

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

Assessment of cardiorespiratory function

Pulmonary function OTHER

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

Assessment of cardiorespiratory function

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Study Officials

• Justine Paysal

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 4, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)