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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04665440
Other study ID # 2020-00101
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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