Clinical Trials Directory

Trials / Terminated

TerminatedNCT04665440

Response of Preterm Infants to Multisensory Stimuli

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
University Hospital, Geneva · Academic / Other
Sex
All
Age
32 Weeks – 35 Weeks
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERVoice alonemother's voice without tactile stimuli
OTHERVoice + tactile stimulimother's voice with tactile stimuli

Timeline

Start date
2020-09-01
Primary completion
2022-11-03
Completion
2022-11-03
First posted
2020-12-11
Last updated
2023-05-10

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04665440. Inclusion in this directory is not an endorsement.