- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03977545
Actigraphy and Neonatal Abstinence Syndrome (ACTINEO)
Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elodie LECORPS
- Phone Number: 0231272055
- Email: lecorps-e@chu-caen.fr
Study Contact Backup
- Name: Bernard GUILLOIS
- Phone Number: 0231272564
- Email: guillois-b@chu-caen.fr
Study Locations
-
-
-
Caen, France
- Recruiting
- Caen Univerity Hospital
-
Contact:
- Lecorps Elodie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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 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.
|
Other: Eutrophic term newborn
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
|
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.
|
Other: 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 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.
|
Other: Eutrophic premature newborn
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between actigraphy and Lipsitz scoring system
Time Frame: ninety minutes after feeding
|
Actigraphy and Lipsitz scoring system are realized at the same time twice a day
|
ninety minutes after feeding
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A02290-55
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal Abstinence Syndrome
-
Indiana UniversityCompletedNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal Syndrome | Neonatal Opioid WithdrawalUnited States
-
Milton S. Hershey Medical CenterNational Institute on Drug Abuse (NIDA)RecruitingNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal SyndromeUnited States
-
Spark Biomedical, Inc.Medical University of South Carolina; University of Texas Southwestern Medical...RecruitingNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal SyndromeUnited States
-
Thomas Jefferson UniversityChiesi Farmaceutici S.p.A.CompletedNeonatal Abstinence Syndrome | Neonatal Opiate Withdrawal SyndromeUnited States
-
PediatrixCompletedNeonatal Abstinence Syndrome | Neonatal Withdrawal SyndromeUnited States
-
Tufts Medical CenterCompletedNeonatal Abstinence Syndrome | Neonatal Opioid WithdrawalUnited States
-
Tulane UniversityRecruitingNeonatal Abstinence Syndrome | Substance Withdrawal, NeonatalUnited States
-
University of VermontNational Institute on Drug Abuse (NIDA); Johns Hopkins University; University... and other collaboratorsCompletedOpioid-use Disorder | Neonatal Abstinence Syndrome | Opioid Withdrawal | Neonatal Opioid Withdrawal SyndromeUnited States
-
University of AlbertaAlberta Health services; Alberta Innovates Health Solutions; Covenant HealthRecruitingNeonatal Abstinence SyndromeCanada
-
University Hospital, CaenRecruitingNeonatal Abstinence SyndromeFrance
Clinical Trials on Actigraphy
-
Mackay Memorial HospitalEnrolling by invitationHeart Failure | Fatigue | Sleep Quality | Heart Rate Variability | FootbathTaiwan
-
The Hospital for Sick ChildrenUniversity of Alabama at Birmingham; Queen's UniversityCompletedPediatric Multiple SclerosisCanada
-
Tel-Aviv Sourasky Medical CenterUnknownSleep Disturbances | Chronic Otitis Media With EffusionIsrael
-
University Hospital, BordeauxCompletedObstructive Sleep Apnea | Sleep Apnea | Nasal ObstructionFrance
-
Mayo ClinicSleep Number, Inc.Active, not recruitingCoronary Artery Disease | Sleep Disorder; Breathing-Related | Sleep Disorder; Insomnia TypeUnited States
-
University of SurreyUniversity of California, San FranciscoCompleted
-
Baylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)CompletedHIV Infections | SleepUnited States
-
Philips Clinical & Medical Affairs GlobalCompleted
-
Taipei Medical UniversityTaipei Medical University Hospital; Taipei Medical University WanFang Hospital and other collaboratorsCompletedNeoplasm of Breast (Disorder) | Carcinoma of Prostate (Disorder)Taiwan
-
Hospital Clinic of BarcelonaCompleted