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

Premature Birth Clinical Trial

— PREMOLF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04906577
• Other study ID #: 19-PP-05
• Status: Terminated
• Phase: N/A
• Start date: September 12, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ocytocine levels		Day 4