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NCT04983563 Clinical Trial

Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units

Neonatal Abstinence Syndrome Clinical Trial

— ACTINEO2  

Official title:
Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04983563
Other study ID # Elodie LECORPS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2022

Study information
Verified date May 2021
Source University Hospital, Caen
Contact Elodie EL LECORPS
Phone 02 31 27 25 71
Email lecorps-e@chu-caen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Actigraphy, eTact
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.

Locations
Country Name City State
France Caen University 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 7 days
See also
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Completed NCT01958476 - Improving Outcomes in Neonatal Abstinence Syndrome Phase 3
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Completed NCT03670160 - Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome Phase 2
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Completed NCT01452789 - Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome Phase 3
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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
Completed NCT04298853 - Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome Phase 4
Completed NCT02182973 - Donor Human Milk in Neonatal Abstinence Syndrome
Completed NCT02810782 - How to Treat Opiate Withdrawal in Neonates Phase 3