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Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology

Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04906577
Acronym
PREMOLF
Enrollment
6
Registered
2021-05-28
Start date
2021-09-12
Completion date
2022-09-15
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Brief summary

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.

Interventions

OTHERphotography+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.

A neutral smelling cloth will be placed with the child's photograph which will then be given to the mother.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in ocytocine levelsDay 4

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026