Back to resultsActigraphy and Neonatal Abstinence Syndrome (ACTINEO)
Primary Purpose
Neonatal Abstinence Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Actigraphy
Sponsored by
About this trial
This is an interventional basic science trial for Neonatal Abstinence Syndrome
Eligibility Criteria
Inclusion Criteria:
- Newborn > 32 weeks of gestation + 0 day
Exclusion Criteria:
- perinatal asphyxia
- 5- minute Apgar score < 7
- ante or post-natal brain injury diagnosis
- upper arm motor deficit
- hospitalization in intensive care unit
- neonatal respiratory distress
Sites / Locations
- Caen Univerity HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Newborn with risk of neonatal opioid abstinence syndrome
Eutrophic term newborn
Term newborn with low birth weight
Eutrophic premature newborn
Arm Description
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 7 days
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
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
NCT03977545
Brief Title
Actigraphy and Neonatal Abstinence Syndrome
Acronym
ACTINEO
Official Title
Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (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
5. Study Description
Brief Summary
The aim of our study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome.
Detailed Description
Neonatal opioid abstinence syndrome occurs after birth when opioids were used by the mother during pregnancy.
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.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Newborn with risk of neonatal opioid abstinence syndrome
Arm Type
Other
Arm Description
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 7 days
Arm Title
Eutrophic term newborn
Arm Type
Other
Arm Description
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
Arm Title
Term newborn with low birth weight
Arm Type
Other
Arm Description
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
Arm Title
Eutrophic premature newborn
Arm Type
Other
Arm Description
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
Intervention Type
Diagnostic Test
Intervention Name(s)
Actigraphy
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 in each arm.
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
ninety minutes after feeding
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Newborn > 32 weeks of gestation + 0 day
Exclusion Criteria:
perinatal asphyxia
5- minute Apgar score < 7
ante or post-natal brain injury diagnosis
upper arm motor deficit
hospitalization in intensive care unit
neonatal respiratory distress
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie LECORPS
Phone
0231272055
Email
lecorps-e@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard GUILLOIS
Phone
0231272564
Email
guillois-b@chu-caen.fr
Facility Information:
Facility Name
Caen Univerity Hospital
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lecorps Elodie
12. IPD Sharing Statement
Learn more about this trial
Actigraphy and Neonatal Abstinence Syndrome
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