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Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology (PREMOLF)

C

Centre Hospitalier Universitaire de Nice

Status

Terminated

Conditions

Premature Birth

Treatments

Other: photography+odour
Other: photography

Study type

Interventional

Funder types

Other

Identifiers

NCT04906577
19-PP-05

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

6 participants in 2 patient groups

VIZOLF
Experimental group
Description:
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
Treatment:
Other: photography+odour
VIZ
Experimental group
Description:
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
Treatment:
Other: photography

Trial contacts and locations

1

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Central trial contact

Florence CASAGRANDE, Dr

Data sourced from clinicaltrials.gov

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