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Clinical Trials/NCT04906577
NCT04906577
Terminated
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country6 target enrollmentSeptember 12, 2021
ConditionsPremature Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
6
Locations
1
Primary Endpoint
Change in ocytocine levels
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2021
End Date
September 15, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in ocytocine levels

Time Frame: Day 4

Study Sites (1)

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