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NCT03977545 Clinical Trial

Actigraphy and Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome Clinical Trial

— ACTINEO  

Official title:
Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03977545
Other study ID # 2018-A02290-55
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 23, 2019
Est. completion date December 31, 2021

Study information
Verified date April 2021
Source University Hospital, Caen
Contact Elodie LECORPS
Phone 0231272055
Email lecorps-e@chu-caen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of our study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 1 Day
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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.

Locations
Country Name City State
France Caen Univerity Hospital Caen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT03890562 - Assessing the Effects of Auricular Acupressure on Newborns With NAS N/A
Completed NCT01958476 - Improving Outcomes in Neonatal Abstinence Syndrome Phase 3
Active, not recruiting NCT01734551 - NAS Treatment - Opiate Versus Non-Opiate Phase 4
Completed NCT00496951 - Vagal Tone and Neonatal Abstinence Syndrome N/A
Completed NCT02851303 - Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome Phase 4
Recruiting NCT05226624 - The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program N/A
Completed NCT03670160 - Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome Phase 2
Not yet recruiting NCT04611659 - Averting NAS Among Opioid-Using Young Women Receiving MAT Using Buprenorphine N/A
Completed NCT01452789 - Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome Phase 3
Completed NCT04588519 - tAN to Mitigate Withdrawal Behaviors in Neonates N/A
Completed NCT02797990 - Conflict Between Maternal Autonomy and Child Health in Substance-use N/A
Completed NCT02801331 - Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome N/A
Terminated NCT03246243 - Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
Completed NCT03567603 - Sound Processing Changes in Babies With Opioid Exposure
Recruiting NCT06303986 - Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
Active, not recruiting NCT03725332 - The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky N/A
Recruiting NCT04983563 - Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units N/A
Completed NCT04298853 - Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome Phase 4
Completed NCT02182973 - Donor Human Milk in Neonatal Abstinence Syndrome