Actigraphy and Neonatal Abstinence Syndrome (ACTINEO)

Caen University Hospital

Status: Unknown

Conditions: Neonatal Abstinence Syndrome

Treatments: Diagnostic Test: Actigraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT03977545

2018-A02290-55

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 1 day old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Newborn with risk of neonatal opioid abstinence syndrome

Other group

Description:

The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 7 days

Treatment:

Diagnostic Test: Actigraphy

Eutrophic term newborn

Other group

Description:

The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days

Treatment:

Diagnostic Test: Actigraphy

Term newborn with low birth weight

Other group

Description:

The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days

Treatment:

Diagnostic Test: Actigraphy

Eutrophic premature newborn

Other group

Description:

The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days

Treatment:

Diagnostic Test: Actigraphy