Response of Preterm Infants to Multisensory Stimuli

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-11-03

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.

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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.

Conditions

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Mother-Infant Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

prospective randomised crossover study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Voice only then distraction

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

Group Type OTHER

Voice alone

Intervention Type OTHER

mother's voice without tactile stimuli

Voice + tactile stimuli

Intervention Type OTHER

mother's voice with tactile stimuli

Distraction then voice only

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

Group Type OTHER

Voice alone

Intervention Type OTHER

mother's voice without tactile stimuli

Voice + tactile stimuli

Intervention Type OTHER

mother's voice with tactile stimuli

Interventions

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Voice alone

mother's voice without tactile stimuli

Intervention Type OTHER

Voice + tactile stimuli

mother's voice with tactile stimuli

Intervention Type OTHER

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

Minimum Eligible Age

32 Weeks

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No