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

NCT ID: NCT04906577

Last Updated: 2024-02-07

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-12

Study Completion Date

2022-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

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

Group Type EXPERIMENTAL

photography+odour

Intervention Type OTHER

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

Group Type EXPERIMENTAL

photography

Intervention Type OTHER

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.

Intervention Type OTHER

photography

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Other Identifiers

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19-PP-05

Identifier Type: -

Identifier Source: org_study_id

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