Response of Preterm Infants to Multisensory Stimuli
- Conditions
- Mother-Infant Interaction
- Interventions
- Other: Voice aloneOther: Voice + tactile stimuli
- Registration Number
- NCT04665440
- Lead Sponsor
- University Hospital, Geneva
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Voice only then distraction Voice alone First intervention: mother's voice without tactile stimuli Second intervention: mother's voice with tactile stimuli Distraction then voice only Voice + tactile stimuli First intervention: mother's voice with tactile stimuli Second intervention: mother's voice without tactile stimuli Distraction then voice only Voice alone First intervention: mother's voice with tactile stimuli Second intervention: mother's voice without tactile stimuli Voice only then distraction Voice + tactile stimuli First intervention: mother's voice without tactile stimuli Second intervention: mother's voice with tactile stimuli
- Primary Outcome Measures
Name Time Method Oxytocin/cortisol ratio at baseline and 10 minutes after intervention Change in salivary oxytocin/cortisol ratio in response to the intervention
- Secondary Outcome Measures
Name Time Method mother anxiety and mother infant bond at baseline and 10 minutes after intervention Level of the mothers anxiety and her bond to the infant analyzed using NICU-PSS questionnaires
Facial expression analysis at baseline, during and 10 minutes after intervention Response of neonate to intervention analysed by standardized neonatal facial coding system score, measured on video recording before, during and after the intervention
Vital signs at baseline, during and 10 minutes after intervention Change in heart rate and respiratory rate in response to the intervention
Trial Locations
- Locations (1)
Hôpitaux Universitaires Genève
🇨🇭Geneva, Switzerland