Response of Preterm Infants to Multisensory Stimuli (OXYVOICE)

May 8, 2023 updated by: Prof. Olivier BAUD, MD-PhD, University Hospital, Geneva

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Hôpitaux Universitaires Genève

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 8 months (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxytocin/cortisol ratio
Time Frame: at baseline and 10 minutes after intervention
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
Time Frame: at baseline, during and 10 minutes after intervention
Change in heart rate and respiratory rate in response to the intervention
at baseline, during and 10 minutes after intervention
Facial expression analysis
Time Frame: 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
at baseline, during and 10 minutes after intervention
mother anxiety and mother infant bond
Time Frame: at baseline and 10 minutes after intervention
Level of the mothers anxiety and her bond to the infant analyzed using NICU-PSS questionnaires
at baseline and 10 minutes after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

November 3, 2022

Study Completion (Actual)

November 3, 2022

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 10, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-00101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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