Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns (NEOMOUV)

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.

Study Overview

• Status: Recruiting
• Conditions: Newborn Infant
• Intervention / Treatment: Other: Heart rate variability; Other: Pulmonary function

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LISE LACLAUTRE; Phone Number: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Contact: LISE LACLAUTRE; Phone Number: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Justine PAYSAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Assessment of cardiorespiratory function; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	during the child's second night
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)	during the child's second night
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)	during the child's second night
Heart rate variability	Others parameters of heart rate variabilt obtained from a Holter ECG recording by SD1 (standard deviation 1)	during the child's second night
Heart rate variability	Others parameters of heart rate variabilt obtained from a Holter ECG recording by and HF (high frequency power)	during the child's second night
Heart rate variability	Others parameters of heart rate variabilt obtained from a Holter ECG recording by SD2 (standard deviation 2)	during the child's second night
Heart rate variability	Others parameters of heart rate variabilt obtained from a Holter ECG recording by SD1/SD2 ratio	during the child's second night
Heart rate variability	Others parameters of heart rate variabilt obtained from a Holter ECG recording by LF (low frequency)	during the child's second night
Respiratory function	Assessed by oximetry: desaturation index and drop per hour of more than 3%.	During the child's second night
Respiratory function	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)	During the child's second night
Respiratory function	Assessed by oximetry: mean saturation (in raw value and in two classes depending on whether the value is strictly less than 93)	During the child's second night
Height growth	height measurement in centimeters	at 2 years old
weight growth	weight measurement in kilograms	at 2 years old
neurodevelopment	assessed by the Ages & Stages Questionnaires, Third Edition (ASQ-3)	at 24 months

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Justine Paysal, CHU de Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: heart rate variability; oximetry
• Other Study ID Numbers: RBHP 2025 PAYSAL; 2025-A00329-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No