Response of Preterm Infants to Multisensory Stimuli

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mother-Infant Interaction

Intervention / Treatment
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* Other: Voice alone
* Other: Voice + tactile stimuli


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: prospective randomised crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Voice only then distraction<br>First intervention: mother's voice without tactile stimuli Second intervention: mother's voice with tactile stimuli | Other: Voice alone<br>* mother's voice without tactile stimuli<br>Other: Voice + tactile stimuli<br>* mother's voice with tactile stimuli<br>|
| Other: Distraction then voice only<br>First intervention: mother's voice with tactile stimuli Second intervention: mother's voice without tactile stimuli | Other: Voice alone<br>* mother's voice without tactile stimuli<br>Other: Voice + tactile stimuli<br>* mother's voice with tactile stimuli<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxytocin/cortisol ratio | Change in salivary oxytocin/cortisol ratio in response to the intervention | at baseline and 10 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs | Change in heart rate and respiratory rate in response to the intervention | at baseline, during and 10 minutes after intervention | 
| Facial expression analysis | Response of neonate to intervention analysed by standardized neonatal facial coding system score, measured on video recording before, during and after the intervention | at baseline, during and 10 minutes after intervention | 
| mother anxiety and mother infant bond | Level of the mothers anxiety and her bond to the infant analyzed using NICU-PSS questionnaires | at baseline and 10 minutes after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonates, oxytocin, late preterm, stress, family-centered intervention