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
50 participants
INTERVENTIONAL
2019-01-23
2021-12-31
Brief Summary
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Detailed Description
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Many scoring systems, like Lipsitz scoring system, are used to diagnose and manage neonatal abstinence syndrome but they are subjective. The majority of items in these scores are motor skills items.
Actigraphy allows to measure objectively the newborn motricity. We will analyse the correlation between actigraphy and Lipsitz scoring system in four groups of newborns.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Newborn with risk of neonatal opioid abstinence syndrome
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 7 days
Actigraphy
Actigraphy will be realized twice a day during 30 minutes and Lipsitz scoring system will be realized at the same moment to analyze the correlation between Lipsitz scoring system and actigraphy in each arm.
Eutrophic term newborn
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
Actigraphy
Actigraphy will be realized twice a day during 30 minutes and Lipsitz scoring system will be realized at the same moment to analyze the correlation between Lipsitz scoring system and actigraphy in each arm.
Term newborn with low birth weight
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
Actigraphy
Actigraphy will be realized twice a day during 30 minutes and Lipsitz scoring system will be realized at the same moment to analyze the correlation between Lipsitz scoring system and actigraphy in each arm.
Eutrophic premature newborn
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
Actigraphy
Actigraphy will be realized twice a day during 30 minutes and Lipsitz scoring system will be realized at the same moment to analyze the correlation between Lipsitz scoring system and actigraphy in each arm.
Interventions
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Actigraphy
Actigraphy will be realized twice a day during 30 minutes and Lipsitz scoring system will be realized at the same moment to analyze the correlation between Lipsitz scoring system and actigraphy in each arm.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 5- minute Apgar score \< 7
* ante or post-natal brain injury diagnosis
* upper arm motor deficit
* hospitalization in intensive care unit
* neonatal respiratory distress
1 Day
ALL
Yes
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Locations
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Caen Univerity Hospital
Caen, , France
Countries
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Central Contacts
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Facility Contacts
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Lecorps Elodie
Role: primary
Other Identifiers
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2018-A02290-55
Identifier Type: -
Identifier Source: org_study_id
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