Response of Preterm Infants to Multisensory Stimuli

University Hospital, Geneva28 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Mother-Infant Interaction

Interventions

Voice aloneOTHER

mother's voice without tactile stimuli

Voice + tactile stimuliOTHER

mother's voice with tactile stimuli

Eligibility

Sex: ALLMin age: 32 WeeksMax age: 35 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Hôpitaux Universitaires Genève

Geneva, Switzerland

Outcomes

Primary Outcomes

Oxytocin/cortisol ratio

Change in salivary oxytocin/cortisol ratio in response to the intervention

Time frame: at baseline and 10 minutes after intervention

Secondary Outcomes

Vital signs

Change in heart rate and respiratory rate in response to the intervention

Time frame: 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

Time frame: 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

Time frame: at baseline and 10 minutes after intervention

Data from ClinicalTrials.gov

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