Actigraphy and Neonatal Abstinence Syndrome (ACTINEO)

April 30, 2021 updated by: University Hospital, Caen

Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome

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

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Caen, France
        • Recruiting
        • Caen Univerity Hospital
        • Contact:
          • Lecorps Elodie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Other: Eutrophic term newborn
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
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.
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
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.
Other: Eutrophic premature newborn
The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

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

No

Studies a U.S. FDA-regulated device product

No

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.

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