Response of Preterm Infants to Multisensory Stimuli

Mother-Infant Interaction Clinical Trial

— OXYVOICE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04665440
• Other study ID #: 2020-00101
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: November 3, 2022

Study information

• Verified date: May 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: November 3, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks to 35 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Mother-Infant Interaction

Intervention

Other:
• Voice alone
mother's voice without tactile stimuli
• Voice + tactile stimuli
mother's voice with tactile stimuli

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (6)

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. — View Citation

Kuhn 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. — View Citation

Lejeune 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. — View Citation

Vittner 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. — View Citation

Weber 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. — View Citation

Zinni 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxytocin/cortisol ratio	Change in salivary oxytocin/cortisol ratio in response to the intervention	at baseline and 10 minutes after intervention
Secondary	Vital signs	Change in heart rate and respiratory rate in response to the intervention	at baseline, during and 10 minutes after intervention
Secondary	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	at baseline, during and 10 minutes after intervention
Secondary	mother anxiety and mother infant bond	Level of the mothers anxiety and her bond to the infant analyzed using NICU-PSS questionnaires	at baseline and 10 minutes after intervention