Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
NCT ID: NCT04906577
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2021-09-12
2022-09-15
Brief Summary
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The immediate and long-term consequences of this "sensory rupture" are widely documented in the child, but little studied in the mother.
The hypothesis at the origin of this work is that olfactory stimulations emanating from the newborn would allow a perceptive continuity between the newborn and his mother. In the pathological situation of the birth of a premature child, these stimulations would lead to neurobiological and behavioural modifications in the mother and would play a role in the attachment process.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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VIZOLF
visual stimulus (photograph of the child) and olfactory stimulus ad libitum, with a minimum of 6 stimulations per day, to the body odour emitted by the child during the first 5 days of life
photography+odour
Daily from D0 to D5: a square of cotton cloth will be placed against the child's scalp by the childcare worker in charge of the child, then removed and placed in a sealed box containing a photograph of the child, which will then be given to the mother.
VIZ
visual stimulus (photograph of the child) and olfactory stimulus ad libitum, with a minimum of 6 stimulations per day, to a neutral odour during the first 5 days of life
photography
A neutral smelling cloth will be placed with the child's photograph which will then be given to the mother.
Interventions
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photography+odour
Daily from D0 to D5: a square of cotton cloth will be placed against the child's scalp by the childcare worker in charge of the child, then removed and placed in a sealed box containing a photograph of the child, which will then be given to the mother.
photography
A neutral smelling cloth will be placed with the child's photograph which will then be given to the mother.
Eligibility Criteria
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Inclusion Criteria
* primiparous mothers
* Mothers with vaginal delivery, without oxytocin infusion after delivery
* Mothers planning to breastfeed, with no maternal contraindication to breastfeeding
Exclusion Criteria
* Use of medication: antidepressants or psychotropic drugs or centrally acting anti-emetics
* Active depression or history of depression (under medical care with medical follow-up) in the year preceding the birth, on questioning
* Chromosomal abnormality or congenital malformation of pre- or post-natal diagnosis in the newborn
* Language barrier not allowing proper explanation of the protocol and responses to questionnaires
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Florence CASAGRANDE, Dr
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire de Nice
Locations
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CHU de Nice
Nice, , France
Countries
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Other Identifiers
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19-PP-05
Identifier Type: -
Identifier Source: org_study_id
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