Actigraphy and Neonatal Abstinence Syndrome
Not Applicable
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Diagnostic Test: Actigraphy
- Registration Number
- NCT03977545
- Lead Sponsor
- University Hospital, Caen
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eutrophic premature newborn Actigraphy The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days Eutrophic term newborn Actigraphy The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days Newborn with risk of neonatal opioid abstinence syndrome Actigraphy The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 7 days Term newborn with low birth weight Actigraphy The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days
- Primary Outcome Measures
Name Time Method Correlation between actigraphy and Lipsitz scoring system ninety minutes after feeding Actigraphy and Lipsitz scoring system are realized at the same time twice a day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Caen Univerity Hospital
🇫🇷Caen, France