Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants
NCT ID: NCT05404594
Last Updated: 2023-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2019-07-17
2023-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Very preterm infant
Preterm infant below 33 weeks of GA
Maternal vocal contact
Two consecutive venipuncture (order randomly balanced) within a short period of time will be realized with and without the presence of the mother talking/singing to her VPI infant.
In this intervention group, the mother will be supported to talk or to sing to her infants during before and during the venipuncture.
Full term neonate
Term neonate from a gestational age of 37 weeks.
Maternal vocal contact
Two consecutive venipuncture (order randomly balanced) within a short period of time will be realized with and without the presence of the mother talking/singing to her VPI infant.
In this intervention group, the mother will be supported to talk or to sing to her infants during before and during the venipuncture.
Interventions
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Maternal vocal contact
Two consecutive venipuncture (order randomly balanced) within a short period of time will be realized with and without the presence of the mother talking/singing to her VPI infant.
In this intervention group, the mother will be supported to talk or to sing to her infants during before and during the venipuncture.
Eligibility Criteria
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Inclusion Criteria
* Control group: Healthy full-term babies (\> 37 weeks gestational age) hospitalized in the maternity ward of Strasbourg University Hospital
* Consent obtained from both parents
* Subject affiliated to a social health insurance plan.
Exclusion Criteria
* Cerebral lesions discovered on cerebral ultrasound performed as part of the standard management of newborns (Intra-Ventricular Hemorrhages of grade III or IV of the Papile classification, Periventricular Leucomalacia)
* Unstable clinical status according to the investigator's judgment
* Expected transfer of the child to another hospital before the term of 40 weeks PMAs.
ALL
Yes
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Service de Pédiatrie - Hôpital d'Hautepierre
Strasbourg, , France
Countries
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Facility Contacts
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Other Identifiers
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7256
Identifier Type: -
Identifier Source: org_study_id
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