Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665440
Status:
TERMINATED
Last Update Posted:
2023-05-10
First Post:
2020-12-03
Brief Title:
Response of Preterm Infants to Multisensory Stimuli
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Variation of Salivary Oxytocin and Cortisol Levels in Premature Neonates and Their Mothers in Response to Multi-sensory Stimuli
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OXYVOICE
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 oxytocincortisol ratio will be occurred in neonates after hearing their mothers and that simultaneous tactile stimulation will mitigate that effect
Concomitantly the neonates 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
Investigators hypothesize that an increase in the oxytocincortisol ratio will be occurred in neonates after hearing their mothers and that simultaneous tactile stimulation will mitigate that effect
Concomitantly the neonates 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None