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

Not Applicable

Terminated

• Conditions: Premature Birth
• Interventions: Other: photography+odour; Other: photography

• Registration Number: NCT04906577
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Study Start: 2021-09-12
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIZOLF	photography+odour	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
VIZ	photography	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

Primary Outcome Measures

Name	Time	Method
Change in ocytocine levels	Day 4

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France