Actigraphy and Neonatal Abstinence Syndrome
ACTINEO
Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome
1 other identifier
interventional
50
1 country
1
Brief Summary
The aim of our study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 23, 2019
CompletedFirst Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMay 3, 2021
April 1, 2021
2.9 years
June 5, 2019
April 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between actigraphy and Lipsitz scoring system
Actigraphy and Lipsitz scoring system are realized at the same time twice a day
ninety minutes after feeding
Study Arms (4)
Newborn with risk of neonatal opioid abstinence syndrome
OTHERThe newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 7 days
Eutrophic term newborn
OTHERThe newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
Term newborn with low birth weight
OTHERThe newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
Eutrophic premature newborn
OTHERThe newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
Interventions
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
You may qualify if:
- Newborn \> 32 weeks of gestation + 0 day
You may not qualify if:
- perinatal asphyxia
- minute Apgar score \< 7
- ante or post-natal brain injury diagnosis
- upper arm motor deficit
- hospitalization in intensive care unit
- neonatal respiratory distress
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Caen Univerity Hospital
Caen, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
June 6, 2019
Study Start
January 23, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
May 3, 2021
Record last verified: 2021-04