Newborn InfantNEOMOUVNCT07264400
Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns
A study testing Heart rate variability and Pulmonary function in people with Newborn Infant, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Newborn Infant
- What is being tested?
- Heart rate variability and Pulmonary function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2025to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Justine PAYSAL
About this study
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.
Read the 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.
- Conditions
- Newborn Infant
- Being tested
- Heart rate variability, Pulmonary function
- Keywords
- heart rate variability, oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variabilityOther
A Holter ECG recording will be performed on the child's second night for a minimum of 6 hours.
Pulmonary functionOther
Oximetry recording will be performed on the child's second night for a minimum of 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Heart rate variability; Other: Pulmonary function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the child's second night.
Secondary outcomes (14)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: during the child's second night
Respiratory function
Assessed by oximetry: desaturation index and drop per hour of more than 3%.
Measured: 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)
Measured: 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)
Measured: During the child's second night
Height growth
height measurement in centimeters
Measured: at 2 years old
weight growth
weight measurement in kilograms
Measured: at 2 years old
neurodevelopment
assessed by the Ages \& Stages Questionnaires, Third Edition (ASQ-3)
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start15 Oct 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn InfantStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine Paysal, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264400
- Sponsor's protocol ID
- RBHP 2025 PAYSAL
- Other IDs
- 2025-A00329-40
- Acronym
- NEOMOUV
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Activity During Pregnancy on Cardiac Variability in Newborns
- ClinicalTrials.gov ID
- NCT07264400
- Acronym / sponsor ID
- NEOMOUV / RBHP 2025 PAYSAL
- Conditions
- Newborn Infant
- Keywords
- heart rate variability, oximetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of cardiorespiratory function | Experimental | Other: Heart rate variability, Other: Pulmonary functionA 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. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variabilityA Holter ECG recording will be performed on the child's second night for a minimum of 6 hours. | Other | Assessment of cardiorespiratory function |
| Pulmonary functionOximetry recording will be performed on the child's second night for a minimum of 6 hours. | Other | Assessment of cardiorespiratory function |
Primary outcome
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.
14 secondary outcomes
Heart rate variability
Time frame: during the child's second night
Heart rate variability
Time frame: during the child's second night
Heart rate variability
Time frame: during the child's second night
Heart rate variability
Time frame: during the child's second night
Heart rate variability
Time frame: during the child's second night
Heart rate variability
Time frame: during the child's second night
Heart rate variability
Time frame: during the child's second night
Heart rate variability
Time frame: during the child's second night
Respiratory function
Time frame: During the child's second night
Respiratory function
Time frame: During the child's second night
Respiratory function
Time frame: During the child's second night
Height growth
Time frame: at 2 years old
weight growth
Time frame: at 2 years old
neurodevelopment
Time frame: at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justine Paysal principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate variability and Pulmonary function in people with Newborn Infant, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: during the child's second night.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.