Clinical trial NCT04665440: Response of Preterm Infants to Multisensory Stimuli
Official title: Variation of Salivary Oxytocin and Cortisol Levels in Premature Neonates and Their Mothers in Response to Multi-sensory Stimuli
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mother-Infant Interaction
Keywords: neonates
oxytocin
late preterm
stress
family-centered intervention
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 28
Sex: ALL
Minimum age (years): 32
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective randomised crossover study
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxytocin/cortisol ratio
timeFrame: at baseline and 10 minutes after intervention
Secondary outcomes:
measure: Vital signs
timeFrame: at baseline, during and 10 minutes after intervention
measure: Facial expression analysis
timeFrame: at baseline, during and 10 minutes after intervention
measure: mother anxiety and mother infant bond
timeFrame: at baseline and 10 minutes after intervention
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires Genève
Study officials:
References:
citation: 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.
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.
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.
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.
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.
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.