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

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.

Study Overview

• Status: Terminated
• Conditions: Premature Birth
• Intervention / Treatment: Other: photography+odour; Other: photography

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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.
Experimental: 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	Other: photography; A neutral smelling cloth will be placed with the child's photograph which will then be given to the mother.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in ocytocine levels	Day 4

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Study Director: Florence CASAGRANDE, Dr, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2021
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 19-PP-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No