Response of Preterm Infants to Multisensory Stimuli (OXYVOICE)

University Hospitals (UH)

Status: Terminated

Conditions: Mother-Infant Interaction

Treatments: Other: Voice + tactile stimuli; Other: Voice alone

Study type: Interventional

Funder types: Other

Identifiers

NCT04665440

2020-00101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 32 to 35 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Voice only then distraction

Other group

Description:

First intervention: mother's voice without tactile stimuli Second intervention: mother's voice with tactile stimuli

Treatment:

Other: Voice + tactile stimuli

Other: Voice alone

Distraction then voice only

Other group

Description:

First intervention: mother's voice with tactile stimuli Second intervention: mother's voice without tactile stimuli

Treatment:

Other: Voice + tactile stimuli

Other: Voice alone