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Mother Who Has Given Birth to a Singleton NewbornOD-ALLNCT07616076

Olfactory Communication in the First Days of Life: From Chemical Mechanisms to Improved Breastfeeding

An observational study of Mother Who Has Given Birth to a Singleton Newborn and Mother-newborn Dyad, run by Centre Hospitalier Universitaire Dijon at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

For a newborn, locating and latching onto the mother's breast is the foundational social interaction. This pivotal moment not only influences the newborn's survival but also determines the mother's physiological (lactation) and psychological (attachment) engagement, as well as the long-term health of both the child… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Chemical description of the scent of the breast or a newborn, Breast secretion samples and The newborn and its role in colostrum secretion
How many people
364 participants
Where
1 siteFrance
Study dates
May 2026to May 2032
Phase
Observational
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Breastfeeding women who have given birth to a single newborn / who may be accompanied by their newborn

Who may be able to join

  • Regarding mothers:
  • Individuals who have provided their consent (studies 1, 2, and 3) as well as that of their child (studies 1 and 3).
  • Adults.
  • Birth of a singleton newborn.
  • Breastfeeding woman (studies 1 and 2).
  • Absence of any infectious risk and any prior morbidity during pregnancy, childbirth, and breastfeeding (determined by medical staff).
  • Regarding newborns:
  • Absence of medical problems during pregnancy, at delivery (full-term birth: 37-42 weeks of amenorrhea, Apgar score > 7 at 1 and 10 minutes; birth weight > 2500 g), or during the neonatal period.

Who cannot join

  • Regarding mothers:
  • Any mother with an infectious disease (HIV, hepatitis A or B) or under special medical supervision.
  • Mothers taking medication that may alter body odor (e.g., corticosteroids, progestins, antidepressants).
  • Mothers who smoke.
  • Mothers suffering from chronic (confirmed congenital anosmia) or acute impairments of the sense of smell (nasal congestion due to infection or allergy).
  • Mothers subject to legal protective measures (guardianship, conservatorship).
Show all 10Show fewer
  • Mothers subject to judicial protective measures.
  • Regarding newborns:
  • Any child who experienced medical problems during pregnancy, childbirth, or the neonatal period (Apgar score < 7 at 1, 5, and 10 minutes).
  • Congenital anosmia (if this information is noted in the medical record; for example, in cases of Du Morsier-Kallman syndrome).

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
  • Chu Dijon Bourgogne

    Dijon, 21000

    Emmanuel SIMON, 03.80.29.38.52 ext. +33, emmanuel.simon@chu-dijon.fr

Other trials in France

About this study

For a newborn, locating and latching onto the mother's breast is the foundational social interaction. This pivotal moment not only influences the newborn's survival but also determines the mother's physiological (lactation) and psychological (attachment) engagement, as well as the long-term health of both the child and the mother. However, according to the WHO, three out of five newborns are not exclusively breastfed for the recommended 6 months, and several recent studies point to suboptimal rates of breastfeeding initiation in the maternity ward, partly due to difficulties with oral latching, insufficient sucking, or refusal of the breast. This situation compromises the initial intake of colostrum/milk, as well as the establishment of early emotional bonds. A wealth of research data from biology, psychology, and pediatrics shows that neonatal and maternal sensory experiences play a central role in the initiation of breastfeeding. However, our understanding of the sensory and behavioral mechanisms at play remains unclear. While visual and auditory interactions have been extensively documented, other sensory modalities-touch, chemoreception, and kinesthesia-remain largely overlooked, even though their critical role has been documented in other mammals. The inves will focus on the role of olfaction in organizing the adaptive responses of the newborn to the mother's breast and of the mother to her baby.

A wealth of research data from biology, psychology, and pediatrics shows that neonatal and maternal sensory experiences play a central role in the initiation of breastfeeding. However, our understanding of the sensory and behavioral mechanisms involved remains unclear. While visual and auditory interactions have been extensively documented, other sensory modalities-touch, chemoreception, and kinesthesia-have received little attention, even though their critical role has been documented in other mammals. Here, the investigators will focus on the role of olfaction in organizing the adaptive responses of the newborn to the mother's breast and of the mother to her baby.

Read more

Research data in humans show that: 1) several mammary secretions (colostrum/milk, areolar secretions) emit odorous compounds, and 2) newborns respond to them in a stereotypical and repeatable manner. These odors, which are specific to the mammary gland, serve to facilitate the very first mother-infant interactions. However, the source of these odorous compounds remains unclear, and their chemical nature is unknown. Without precise chemical identification, it is difficult to fully understand the mechanisms by which odors influence the newborn's behavior toward the mother's breast at the start of breastfeeding. Conversely, the newborn's body odors could also convey information about its emotional or metabolic state and influence maternal motivation and behavior.

Based on research conducted on other mammals, as well as studies focused on our own species, the investigators know that: 1) postpartum mothers are highly receptive to the body odor of their newborns, and 2) newborns emit odor compounds that are appreciated by mothers (even if the infants are not their own) . It cannot therefore be ruled out that human mothers react, even unconsciously, to these infant odors and that these odors could help regulate maternal psychophysiology (particularly that underlying lactation and the related chemocommunication mechanisms).

The OD-ALL project aims to unravel the chemical basis of the olfactory interactions that lead to the establishment of the breastfeeding relationship between each member of the mother-newborn dyad. To this end, the investigators will apply an innovative technology, proton transfer reaction time-of-flight mass spectrometry (PTR-ToF-MS), which has previously been used to monitor volatile organic compounds (VOCs) in the environment. Unlike conventional techniques (such as gas chromatography coupled with mass spectrometry; GC-MS), which allow only sporadic and somewhat disruptive measurements, PTR-ToF-MS records odor emissions in real time, without any disruption to the natural interactions taking place. It is capable of providing a true "chemical video" of the dynamic variations in VOCs of mammary or infant origin (whereas conventional GC-MS provides only a "chemical snapshot"). These fluctuations can thus be correlated with the behaviors and physiological responses of mothers and newborns, which will be recorded concurrently. This approach opens up entirely new avenues for understanding the chemosensory foundations of early human interactions, particularly those that occur during the initiation of breastfeeding. Alongside this fundamental approach, the OD-ALL project aims to raise awareness among healthcare professionals, the general public and health policy makers regarding the role of smell in early interactions between mother and newborn.

Being tested
Chemical description of the scent of the breast or a newborn, Breast secretion samples, The newborn and its role in colostrum secretion, Neonatal responsiveness to breast odors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chemical description of the scent of the breast or a newbornOther

    VOC measurement during a breastfeeding session + video and thermographic recording

  • Breast secretion samplesOther

    Breast secretion samples

  • The newborn and its role in colostrum secretionOther

    Measurement of VOCs during a film screening featuring various sensory characteristics of children + video and thermographic recording

  • Neonatal responsiveness to breast odorsOther

    Measurement of psychophysiological responses in sleeping newborns during exposure to maternal odors + video and thermographic recording

  • Neonatal responsiveness to breast odorsOther

    Measurement of sucking responses in awake newborns during exposure to maternal odors + video and thermographic recording

Study groups in NCT07616076
Study groupRoleWhat they receive
44 mother-newborn pairs44 mother-newborn pairs (i.e., n = 44 mothers et n = 44 newborn)
Receives: Other: Chemical description of the scent of the breast or a newborn
42 mothers42 mothers (collection of areolar secretions)
Receives: Other: Breast secretion samples
164 mothers164 mothers
Receives: Other: The newborn and its role in colostrum secretion
57 awake newborns57 awake newborns
Receives: Other: Neonatal responsiveness to breast odors
57 sleeping newborns57 sleeping newborns
Receives: Other: Neonatal responsiveness to breast odors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Temporal variations in the occurrence of VOCs emitted in the odor of the lactating breast, measured in real time using proton transfer mass spectrometry

    Measured: Before, during, and after feeding, at day 0 during 3 hours

  2. Temporal variations in the relative concentration of VOCs emitted in the breath of nursing mothers, measured in real time using proton transfer mass spectrometry

    Measured: Before, during, and after feeding, at day 0 during few minutes

  3. Maternal responsiveness (breast interoception, breast thermography measured by concurrent chemical analysis (PTR-ToF-MS) to identify systematic variations in the VOCs of breast odor) during visual, auditory, and olfactory presentation to the child video

    Measured: While breastfeeding at day 0 during 1 hour

  4. Behavioral responses in newborns exposed to samples of breast milk or to VOCs present in breast milk vapors, as measured by orofacial motor activity in sleeping newborns during active sleep phases

    Measured: While breastfeeding at day O during 30 to 45 minutes

  5. Psychophysiological responses in newborns exposed to samples of breast milk or to VOCs present in breast milk vapors, as measured by heart and respiratory rates in sleeping newborns during active sleep phases

    Measured: While breastfeeding at day O during 30 to 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionMay 2032 (estimated)
  4. Study completionMay 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07616076
Sponsor's protocol ID
SIMON Stirling 2025
Acronym
OD-ALL
Status last verified
May 2026
First submitted
11 May 2026
Last updated
29 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mother Who Has Given Birth to a Singleton Newborn and Mother-newborn Dyad, run by Centre Hospitalier Universitaire Dijon 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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 29 May 2026. 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 Emmanuel SIMON (03.80.29.38.52 ext. +33, emmanuel.simon@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temporal variations in the occurrence of VOCs emitted in the odor of the lactating breast, measured in real time using proton transfer mass spectrometry (time frame: Before, during, and after feeding, at day 0 during 3 hours). The study lists 5 primary outcomes in all. 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 29 May 2026.

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