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slow recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voice only then distraction | Other | First intervention: mother's voice without tactile stimuli Second intervention: mother's voice with tactile stimuli |
|
| Distraction then voice only | Other | First intervention: mother's voice with tactile stimuli Second intervention: mother's voice without tactile stimuli |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voice alone | Other | mother's voice without tactile stimuli |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxytocin/cortisol ratio | Change in salivary oxytocin/cortisol ratio in response to the intervention | at baseline and 10 minutes after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs | Change in heart rate and respiratory rate in response to the intervention | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires Genève | Geneva | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28378337 | Background | 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. | |
| 28699358 | Background | 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. |
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| ID | Term |
|---|---|
| D014831 | Voice |
| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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prospective randomised crossover study
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| Voice + tactile stimuli | Other | mother's voice with tactile stimuli |
|
| 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 | at baseline and 10 minutes after intervention |
| 29017336 | Background | 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. |
| 29706926 | Background | 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. |
| 30144160 | Background | 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. |
| 30025190 | Background | 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. |