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Response of Preterm Infants to Multisensory Stimuli

Variation of Salivary Oxytocin and Cortisol Levels in Premature Neonates and Their Mothers in Response to Multi-sensory Stimuli

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04665440
Acronym
OXYVOICE
Enrollment
28
Registered
2020-12-11
Start date
2020-09-01
Completion date
2022-11-03
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mother-Infant Interaction

Keywords

neonates, oxytocin, late preterm, stress, family-centered intervention

Brief summary

The aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of premature neonates and their mother after sensorial stimuli.

Detailed description

The aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of neonates with gestational age ranging from 32 to 34 completed weeks and in the saliva of their mothers. The measurements are taken before and after sensorial stimuli including mother voice exposure +/- tactile distraction for 10 minutes. The two interventions are performed between day 5 and day 12 after birth and 24 to 48 hours apart. Each child is randomised in a group depending on order of the two interventions. Investigators hypothesize that an increase in the oxytocin/cortisol ratio will be occurred in neonates after hearing their mothers and that simultaneous tactile stimulation will mitigate that effect. Concomitantly, the neonate's vital signs and his facial expressions are recorded during interventions. The mothers anxiety level is assessed PSS-NICU questionnaire given before the first and after the second intervention.

Interventions

OTHERVoice alone

mother's voice without tactile stimuli

OTHERVoice + tactile stimuli

mother's voice with tactile stimuli

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

prospective randomised crossover study

Eligibility

Sex/Gender
ALL
Age
32 Weeks to 35 Weeks
Healthy volunteers
No

Inclusion criteria

* Newborn gestational age 32 0/7 weeks to 34 6/7 weeks * Born at university hospital Geneva * French speaking parents * Out of incubator * Signed consent

Exclusion criteria

* Newborn with one of the above conditions: * Congenital malformation * intraventricular hemorrhage grade III or IV * white matter abnormality * anti-epileptic or sedative drugs * altered consciousness level * Infant requiring respiratory support * psychiatric disorders in the mother or antenatal use of psychoactive drugs * Bilateral absent otoacoustic emissions and/or auditory evoked potential * Parents refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Oxytocin/cortisol ratioat baseline and 10 minutes after interventionChange in salivary oxytocin/cortisol ratio in response to the intervention

Secondary

MeasureTime frameDescription
Vital signsat baseline, during and 10 minutes after interventionChange in heart rate and respiratory rate in response to the intervention
Facial expression analysisat baseline, during and 10 minutes after interventionResponse of neonate to intervention analysed by standardized neonatal facial coding system score, measured on video recording before, during and after the intervention
mother anxiety and mother infant bondat baseline and 10 minutes after interventionLevel of the mothers anxiety and her bond to the infant analyzed using NICU-PSS questionnaires

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026