NewbornSOLANGENCT06268444
Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants
A study testing 7-day actimetry sleep recording, Determination of environmental pollutants in breast milk and Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child in people with Newborn and Chemical Pollutants Exposure, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Newborn, Chemical Pollutants Exposure, Sleep
- What is being tested?
- 7-day actimetry sleep recording, Determination of environmental pollutants in breast milk and Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2024to Feb 2026
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant less than 6 months of age still on milk diet (total)
Who cannot join
- Infants with neurological or neurobehavioral disorders
- Families who wish to relocate within 7 days of inclusion
- Minor parents deprived of their parental rights, not understanding French, in a state of stress, overwhelmed or vulnerable.
- Non-affiliation to a social security system
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
CHRU Amiens
Amiens, 80054
Karen CHARDON, Pr, 03.22.82.78. 65, Karen.chardon@u-picardie.fr
Elodie HARAUX, HARAUX
About this study
Official title: Infant Sleep and Exposure to Mixture of Environmental Pollutants
During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\'s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.
In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\'s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation.
- Conditions
- Newborn, Chemical Pollutants Exposure, Sleep
- Being tested
- 7-day actimetry sleep recording, Determination of environmental pollutants in breast milk, Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child, Continuous recording of the child's temperature for 7 days, Use of a sleep diary for 7 days
- Keywords
- sleep, Newborn, chemical pollutants exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day actimetry sleep recordingDevice
7-day actimetry sleep recording
Determination of environmental pollutants in breast milkOther
Determination of environmental pollutants in breast milk
Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the childOther
Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child
Continuous recording of the child's temperature for 7 daysOther
Continuous recording of the child\'s temperature for 7 days
Use of a sleep diary for 7 daysOther
Use of a sleep diary for 7 days
Parental questionnaire of environmental exposureOther
Parental questionnaire of environmental exposure
| Study group | Role | What they receive |
|---|---|---|
| New born | Experimental | Not described Receives: Device: 7-day actimetry sleep recording; Other: Determination of environmental pollutants in breast milk; Other: Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child; Other: Continuous recording of the child's temperature for 7 days; Other: Use of a sleep diary for 7 days; Other: Parental questionnaire of environmental exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
total sleep time per day in infants using actimetry
total sleep time per day (min)) in infants using actimetry
Measured: 7 days
Secondary outcomes (3)
Concentration of various substances in breast milk
Measured: 1 day
concentration of chemical polluants on newborn bracelets
Measured: 1 day
Child Temperature level (°C)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start7 Feb 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268444
- Sponsor's protocol ID
- PI2023_843_0077
- Acronym
- SOLANGE
- Status last verified
- May 2025
- First submitted
- 13 Feb 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Sleep and Exposure to Mixture of Environmental Pollutants
- ClinicalTrials.gov ID
- NCT06268444
- Acronym / sponsor ID
- SOLANGE / PI2023_843_0077
- Conditions
- Newborn, Chemical Pollutants Exposure, Sleep
- Keywords
- sleep, Newborn, chemical pollutants exposure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 Feb 2024 (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.
During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\'s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.
In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\'s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New born | Experimental | Device: 7-day actimetry sleep recording, Other: Determination of environmental pollutants in breast milk, Other: Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child, Other: Continuous recording of the child's temperature for 7 days, Other: Use of a sleep diary for 7 days, Other: Parental questionnaire of environmental exposure |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infant less than 6 months of age still on milk diet (total)
Key exclusion criteria (4 listed)
- Infants with neurological or neurobehavioral disorders
- Families who wish to relocate within 7 days of inclusion
- Minor parents deprived of their parental rights, not understanding French, in a state of stress, overwhelmed or vulnerable.
- Non-affiliation to a social security system
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 |
|---|---|---|
| 7-day actimetry sleep recording7-day actimetry sleep recording | Device | New born |
| Determination of environmental pollutants in breast milkDetermination of environmental pollutants in breast milk | Other | New born |
| Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the childMeasurements of environmental pollutants in indoor air deposited on the bracelet worn by the child | Other | New born |
| Continuous recording of the child's temperature for 7 daysContinuous recording of the child\'s temperature for 7 days | Other | New born |
| Use of a sleep diary for 7 daysUse of a sleep diary for 7 days | Other | New born |
| Parental questionnaire of environmental exposureParental questionnaire of environmental exposure | Other | New born |
Primary outcome
total sleep time per day in infants using actimetry
Time frame: 7 days
total sleep time per day (min)) in infants using actimetry
3 secondary outcomes
Concentration of various substances in breast milk
Time frame: 1 day
concentration of chemical polluants on newborn bracelets
Time frame: 1 day
Child Temperature level (°C)
Time frame: 7 days
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 22 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-day actimetry sleep recording, Determination of environmental pollutants in breast milk and Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child in people with Newborn and Chemical Pollutants Exposure, run by Centre Hospitalier Universitaire, Amiens 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 1 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 22 May 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 Karen CHARDON, Pr ((33) 03.22.82.78. 65, Karen.chardon@u-picardie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total sleep time per day in infants using actimetry (time frame: 7 days). 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 22 May 2025.