Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology (PREMOLF)
Primary Purpose
Premature Birth
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
photography+odour
photography
Sponsored by
About this trial
This is an interventional other trial for Premature Birth
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
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
VIZOLF
VIZ
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in ocytocine levels
Secondary Outcome Measures
Full Information
NCT ID
NCT04906577
First Posted
May 25, 2021
Last Updated
May 28, 2021
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04906577
Brief Title
Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
Acronym
PREMOLF
Official Title
Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2021 (Anticipated)
Primary Completion Date
August 11, 2023 (Anticipated)
Study Completion Date
August 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VIZOLF
Arm Type
Experimental
Arm Description
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
Arm Title
VIZ
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
photography+odour
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
photography
Intervention Description
A neutral smelling cloth will be placed with the child's photograph which will then be given to the mother.
Primary Outcome Measure Information:
Title
Change in ocytocine levels
Time Frame
Day 4
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florence CASAGRANDE, Dr
Phone
492036434
Ext
+33
Email
casagrande-magne.f@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence CASAGRANDE, Dr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Nice
City
Nice
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence CASAGRANDE, Dr
Phone
492036434
Ext
+33
Email
casagrande-magne.f@chu-nice.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
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