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Actigraphy and Neonatal Abstinence Syndrome

Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03977545
Acronym
ACTINEO
Enrollment
50
Registered
2019-06-06
Start date
2019-01-23
Completion date
2021-12-31
Last updated
2021-05-03

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 our study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome.

Detailed description

Neonatal opioid abstinence syndrome occurs after birth when opioids were used by the mother during pregnancy. 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. We will analyse the correlation between actigraphy and Lipsitz scoring system in four groups of newborns.

Interventions

DIAGNOSTIC_TESTActigraphy

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 in each arm.

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
Yes

Inclusion criteria

* Newborn \> 32 weeks of gestation + 0 day

Exclusion criteria

* perinatal asphyxia * 5- minute Apgar score \< 7 * ante or post-natal brain injury diagnosis * upper arm motor deficit * hospitalization in intensive care unit * neonatal respiratory distress

Design outcomes

Primary

MeasureTime frameDescription
Correlation between actigraphy and Lipsitz scoring systemninety minutes after feedingActigraphy and Lipsitz scoring system are realized at the same time twice a day

Countries

France

Contacts

Primary ContactElodie LECORPS
lecorps-e@chu-caen.fr0231272055
Backup ContactBernard GUILLOIS
guillois-b@chu-caen.fr0231272564

Outcome results

None listed

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