NCT04983563

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 30, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

June 10, 2021

Last Update Submit

July 20, 2021

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (1)

  • Correlation between actigraphy and Lipsitz scoring system

    Actigraphy and Lipsitz scoring system are realized at the same time twice a day

    7 days

Study Arms (1)

Actigraphy

EXPERIMENTAL
Device: Actigraphy, eTact

Interventions

Actigraphy, eTactDEVICE

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.

Actigraphy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newborn \> 22 gestation weeks
  • Hospitalization in neonatal intensive care unit at CHU de Caen.
  • Opioids treatment \> 48 hours.

You may not qualify if:

  • ante or post-natal brain injury diagnosis
  • upper arm motor deficit
  • palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisAccelerometryInvestigative Techniques

Study Officials

  • Elodie EL LECORPS

    CHU CAEN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elodie EL LECORPS

CONTACT

02 31 27 25 71lecorps-e@chu-caen.fr

Bernard BG GUILLOIS

CONTACT

02 31 25 20 62guillois-b@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2021

First Posted

July 30, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

July 30, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)