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

Not Applicable
Conditions
Neonatal Abstinence Syndrome
Interventions
Device: Actigraphy, eTact
Registration Number
NCT04983563
Lead Sponsor
University Hospital, Caen
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ActigraphyActigraphy, eTact-
Primary Outcome Measures
NameTimeMethod
Correlation between actigraphy and Lipsitz scoring system7 days

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Caen University Hospital

🇫🇷

Caen, France

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