Mother-Infant InteractionOXYVOICENCT04665440
Response of Preterm Infants to Multisensory Stimuli
A study testing Voice alone and Voice + tactile stimuli in people with Mother-Infant Interaction, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 35 weeks
- Conditions the study is for
- Mother-Infant Interaction
- What is being tested?
- Voice alone and Voice + tactile stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to 3 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mother-Infant Interaction
- Being tested
- Voice alone, Voice + tactile stimuli
- Keywords
- neonates, oxytocin, late preterm, stress, family-centered intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice aloneOther
mother's voice without tactile stimuli
Voice + tactile stimuliOther
mother's voice with tactile stimuli
| Study group | Role | What they receive |
|---|---|---|
| Voice only then distraction | Other | First intervention: mother's voice without tactile stimuli Second intervention: mother's voice with tactile stimuli Receives: Other: Voice alone; Other: Voice + tactile stimuli |
| Distraction then voice only | Other | First intervention: mother's voice with tactile stimuli Second intervention: mother's voice without tactile stimuli Receives: Other: Voice alone; Other: Voice + tactile stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin/cortisol ratio
Change in salivary oxytocin/cortisol ratio in response to the intervention
Measured: at baseline and 10 minutes after intervention
Secondary outcomes (3)
Vital signs
Change in heart rate and respiratory rate in response to the intervention
Measured: 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
Measured: 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
Measured: at baseline and 10 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Sep 2020
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mother-Infant InteractionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective randomised crossover study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Olivier BAUD, MD-PhD, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665440
- Sponsor's protocol ID
- 2020-00101
- Acronym
- OXYVOICE
- Status last verified
- May 2023
- First submitted
- 3 Dec 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Filippa M, Panza C, Ferrari F, Frassoldati R, Kuhn P, Balduzzi S, D'Amico R. Systematic review of maternal voice interventions demonstrates increased stability in preterm infants. Acta Paediatr. 2017 Aug;106(8):1220-1229. doi: 10.1111/apa.13832. Epub 2017 Apr 19.
PubMed 28378337Weber A, Harrison TM, Sinnott L, Shoben A, Steward D. Plasma and Urinary Oxytocin Trajectories in Extremely Premature Infants During NICU Hospitalization. Biol Res Nurs. 2017 Oct;19(5):549-558. doi: 10.1177/1099800417718266. Epub 2017 Jul 12.
PubMed 28699358Vittner D, McGrath J, Robinson J, Lawhon G, Cusson R, Eisenfeld L, Walsh S, Young E, Cong X. Increase in Oxytocin From Skin-to-Skin Contact Enhances Development of Parent-Infant Relationship. Biol Res Nurs. 2018 Jan;20(1):54-62. doi: 10.1177/1099800417735633. Epub 2017 Oct 11.
PubMed 29017336Zinni M, Colella M, Batista Novais AR, Baud O, Mairesse J. Modulating the Oxytocin System During the Perinatal Period: A New Strategy for Neuroprotection of the Immature Brain? Front Neurol. 2018 Apr 13;9:229. doi: 10.3389/fneur.2018.00229. eCollection 2018.
PubMed 29706926Lejeune F, Brand LA, Palama A, Parra J, Marcus L, Barisnikov K, Debillon T, Gentaz E, Berne-Audeoud F. Preterm infant showed better object handling skills in a neonatal intensive care unit during silence than with a recorded female voice. Acta Paediatr. 2019 Mar;108(3):460-467. doi: 10.1111/apa.14552. Epub 2018 Sep 21.
PubMed 30144160Kuhn P, Sizun J, Casper C; GREEN study group from the French Neonatal Society. Recommendations on the environment for hospitalised newborn infants from the French neonatal society: rationale, methods and first recommendation on neonatal intensive care unit design. Acta Paediatr. 2018 Nov;107(11):1860-1866. doi: 10.1111/apa.14501. Epub 2018 Aug 13.
PubMed 30025190
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation of Salivary Oxytocin and Cortisol Levels in Premature Neonates and Their Mothers in Response to Multi-sensory Stimuli
- ClinicalTrials.gov ID
- NCT04665440
- Acronym / sponsor ID
- OXYVOICE / 2020-00101
- Conditions
- Mother-Infant Interaction
- Keywords
- neonates, oxytocin, late preterm, stress, family-centered intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomised crossover study
| Arm | Type | Receives |
|---|---|---|
| Voice only then distraction | Other | Other: Voice alone, Other: Voice + tactile stimuliFirst intervention: mother's voice without tactile stimuli Second intervention: mother's voice with tactile stimuli |
| Distraction then voice only | Other | Other: Voice alone, Other: Voice + tactile stimuliFirst intervention: mother's voice with tactile stimuli Second intervention: mother's voice without tactile stimuli |
Who may qualify
- Ages
- 32 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Newborn with one of the above conditions:
- Congenital malformation
- intraventricular hemorrhage grade III or IV
- white matter abnormality
- anti-epileptic or sedative drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice alonemother's voice without tactile stimuli | Other | Distraction then voice only, Voice only then distraction |
| Voice + tactile stimulimother's voice with tactile stimuli | Other | Distraction then voice only, Voice only then distraction |
Primary outcome
Oxytocin/cortisol ratio
Time frame: at baseline and 10 minutes after intervention
Change in salivary oxytocin/cortisol ratio in response to the intervention
3 secondary outcomes
Vital signs
Time frame: at baseline, during and 10 minutes after intervention
Facial expression analysis
Time frame: at baseline, during and 10 minutes after intervention
mother anxiety and mother infant bond
Time frame: at baseline and 10 minutes after intervention
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 28378337Filippa M, Panza C, Ferrari F, Frassoldati R, Kuhn P, Balduzzi S, D'Amico R. Systematic review of maternal voice interventions demonstrates increased stability in preterm infants. Acta Paediatr. 2017 Aug;106(8):1220-1229. doi: 10.1111/apa.13832. Epub 2017 Apr 19.
- Background: PubMed 28699358Weber A, Harrison TM, Sinnott L, Shoben A, Steward D. Plasma and Urinary Oxytocin Trajectories in Extremely Premature Infants During NICU Hospitalization. Biol Res Nurs. 2017 Oct;19(5):549-558. doi: 10.1177/1099800417718266. Epub 2017 Jul 12.
- Background: PubMed 29017336Vittner D, McGrath J, Robinson J, Lawhon G, Cusson R, Eisenfeld L, Walsh S, Young E, Cong X. Increase in Oxytocin From Skin-to-Skin Contact Enhances Development of Parent-Infant Relationship. Biol Res Nurs. 2018 Jan;20(1):54-62. doi: 10.1177/1099800417735633. Epub 2017 Oct 11.
- Background: PubMed 29706926Zinni M, Colella M, Batista Novais AR, Baud O, Mairesse J. Modulating the Oxytocin System During the Perinatal Period: A New Strategy for Neuroprotection of the Immature Brain? Front Neurol. 2018 Apr 13;9:229. doi: 10.3389/fneur.2018.00229. eCollection 2018.
- Background: PubMed 30144160Lejeune F, Brand LA, Palama A, Parra J, Marcus L, Barisnikov K, Debillon T, Gentaz E, Berne-Audeoud F. Preterm infant showed better object handling skills in a neonatal intensive care unit during silence than with a recorded female voice. Acta Paediatr. 2019 Mar;108(3):460-467. doi: 10.1111/apa.14552. Epub 2018 Sep 21.
- Background: PubMed 30025190Kuhn P, Sizun J, Casper C; GREEN study group from the French Neonatal Society. Recommendations on the environment for hospitalised newborn infants from the French neonatal society: rationale, methods and first recommendation on neonatal intensive care unit design. Acta Paediatr. 2018 Nov;107(11):1860-1866. doi: 10.1111/apa.14501. Epub 2018 Aug 13.
Related trials for Mother-Infant Interaction
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
Active, not recruiting
Investigating Baby Behavior and Family Technology Use Study
Mobile Phone Use, Mother-Infant Interaction
Recruiting
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
Postpartum Depression, Postpartum Anxiety
Recruiting
The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.
Bonding, ERAS
Recruiting
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
Preterm Birth, Mother-Infant Interaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice alone and Voice + tactile stimuli in people with Mother-Infant Interaction, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxytocin/cortisol ratio (time frame: at baseline and 10 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04665440, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.