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

Caen University Hospital

Status: Unknown

Conditions: Neonatal Abstinence Syndrome

Treatments: Device: Actigraphy, eTact

Study type: Interventional

Funder types: Other

Identifiers

NCT04983563

Elodie LECORPS

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Actigraphy

Experimental group

Treatment:

Device: Actigraphy, eTact