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

Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04983563

Acronym

ACTINEO2

Enrollment

Registered

2021-07-30

Start date

2021-03-01

Completion date

2022-12-31

Last updated

2021-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Abstinence Syndrome

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.

Interventions

DEVICEActigraphy, eTact

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between actigraphy and Lipsitz scoring system	7 days	Actigraphy and Lipsitz scoring system are realized at the same time twice a day

Countries

France

Contacts

Primary ContactElodie EL LECORPS

lecorps-e@chu-caen.fr02 31 27 25 71

Backup ContactBernard BG GUILLOIS

guillois-b@chu-caen.fr02 31 25 20 62

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026