- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07616076
Olfactory Communication in the First Days of Life: From Chemical Mechanisms to Improved Breastfeeding (OD-ALL)
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.
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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Emmanuel SIMON
- Telefonní číslo: +33 03.80.29.38.52
- E-mail: emmanuel.simon@chu-dijon.fr
Studijní místa
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Dijon, Francie, 21000
- CHU Dijon Bourgogne
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Kontakt:
- Emmanuel SIMON
- Telefonní číslo: +33 03.80.29.38.52
- E-mail: emmanuel.simon@chu-dijon.fr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
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.
Exclusion Criteria:
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).
- 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).
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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44 mother-newborn pairs
44 mother-newborn pairs (i.e., n = 44 mothers et n = 44 newborn)
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VOC measurement during a breastfeeding session + video and thermographic recording
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42 mothers
42 mothers (collection of areolar secretions)
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Breast secretion samples
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164 mothers
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Measurement of VOCs during a film screening featuring various sensory characteristics of children + video and thermographic recording
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57 awake newborns
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Measurement of psychophysiological responses in sleeping newborns during exposure to maternal odors + video and thermographic recording
Measurement of sucking responses in awake newborns during exposure to maternal odors + video and thermographic recording
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57 sleeping newborns
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Measurement of psychophysiological responses in sleeping newborns during exposure to maternal odors + video and thermographic recording
Measurement of sucking responses in awake newborns during exposure to maternal odors + video and thermographic recording
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Temporal variations in the occurrence of VOCs emitted in the odor of the lactating breast, measured in real time using proton transfer mass spectrometry
Časové okno: Before, during, and after feeding, at day 0 during 3 hours
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Before, during, and after feeding, at day 0 during 3 hours
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Temporal variations in the relative concentration of VOCs emitted in the breath of nursing mothers, measured in real time using proton transfer mass spectrometry
Časové okno: Before, during, and after feeding, at day 0 during few minutes
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Before, during, and after feeding, at day 0 during few minutes
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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
Časové okno: While breastfeeding at day 0 during 1 hour
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While breastfeeding at day 0 during 1 hour
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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
Časové okno: While breastfeeding at day O during 30 to 45 minutes
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While breastfeeding at day O during 30 to 45 minutes
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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
Časové okno: While breastfeeding at day O during 30 to 45 minutes
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While breastfeeding at day O during 30 to 45 minutes
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- SIMON Stirling 2025
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