Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units (ACTINEO2)
Primary Purpose
Neonatal Abstinence Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Actigraphy, eTact
Sponsored by
About this trial
This is an interventional basic science trial for Neonatal Abstinence Syndrome
Eligibility Criteria
Inclusion Criteria:
- Newborn > 22 gestation weeks
- Hospitalization in neonatal intensive care unit at CHU de Caen.
- Opioids treatment > 48 hours.
Exclusion Criteria :
- ante or post-natal brain injury diagnosis
- upper arm motor deficit
- palliative care
Sites / Locations
- Caen University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Actigraphy
Arm Description
Outcomes
Primary Outcome Measures
Correlation between actigraphy and Lipsitz scoring system
Actigraphy and Lipsitz scoring system are realized at the same time twice a day
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04983563
Brief Title
Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units
Acronym
ACTINEO2
Official Title
Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome of hospitalized newborn in intensive care units
Detailed Description
Hospitalized newborn in intensive care units can receive opioids to manage pain or sedation. Neonatal opioid abstinence syndrome can occur when newborn receive opioid treatment for a long time.
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. This study will analyse the correlation between actigraphy and Lipsitz scoring system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Actigraphy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Actigraphy, eTact
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation between actigraphy and Lipsitz scoring system
Description
Actigraphy and Lipsitz scoring system are realized at the same time twice a day
Time Frame
7 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Newborn > 22 gestation weeks
Hospitalization in neonatal intensive care unit at CHU de Caen.
Opioids treatment > 48 hours.
Exclusion Criteria :
ante or post-natal brain injury diagnosis
upper arm motor deficit
palliative care
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie EL LECORPS
Phone
02 31 27 25 71
Email
lecorps-e@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard BG GUILLOIS
Phone
02 31 25 20 62
Email
guillois-b@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elodie EL LECORPS
Organizational Affiliation
CHU Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units
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