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Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units (ACTINEO2)

Primary Purpose

Neonatal Abstinence Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Actigraphy, eTact
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neonatal Abstinence Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Caen University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Actigraphy

Arm Description

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

First Posted
June 10, 2021
Last Updated
July 20, 2021
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT04983563
Brief Title
Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units
Acronym
ACTINEO2
Official Title
Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (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
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Actigraphy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Actigraphy, eTact
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.
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
7 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie EL LECORPS
Phone
02 31 27 25 71
Email
lecorps-e@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard BG GUILLOIS
Phone
02 31 25 20 62
Email
guillois-b@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elodie EL LECORPS
Organizational Affiliation
CHU Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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