Premature Birth Clinical Trial
— PREMOLFOfficial title:
Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
Verified date | February 2024 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
At birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment. The sensory signals within the mother-infant dyad will lead to behavioural and metabolic adaptations in both individuals. Currently, the conditions of reception of a very premature newborn in the neonatal intensive care unit of the CHU of Nice lead to a separation between mother and child, with a reduction in sensory interactions. 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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | September 15, 2022 |
Est. primary completion date | September 15, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Immediate postpartum mothers of newborns with a term of < 33 weeks (32 weeks + 6 days) - primiparous mothers - Mothers with vaginal delivery, without oxytocin infusion after delivery - Mothers planning to breastfeed, with no maternal contraindication to breastfeeding Exclusion Criteria: - Substance abuse: active smoking at the time of delivery, alcohol, drugs - 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in ocytocine levels | Day 4 |
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