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

NCT04906577 | Terminated

• 1 other identifier: 19-PP-05
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

• Change in ocytocine levels

  Day 4

Study Arms (2)

VIZOLF

EXPERIMENTAL

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

Other: photography+odour

VIZ

EXPERIMENTAL

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

Other: photography

Interventions

photography+odour 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.

VIZOLF

photography OTHER

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

VIZ

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Photography

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Florence CASAGRANDE, Dr

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: September 12, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)