Actigraphy and Neonatal Abstinence Syndrome

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

Detailed Description
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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.

Official Title
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Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome

Conditions
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Neonatal Abstinence Syndrome

Intervention / Treatment
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* Diagnostic Test: Actigraphy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Newborn with risk of neonatal opioid abstinence syndrome<br>The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 7 days | Diagnostic Test: Actigraphy<br>* 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.<br>|
| Other: Eutrophic term newborn<br>The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days | Diagnostic Test: Actigraphy<br>* 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.<br>|
| Other: Term newborn with low birth weight<br>The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days | Diagnostic Test: Actigraphy<br>* 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.<br>|
| Other: Eutrophic premature newborn<br>The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days | Diagnostic Test: Actigraphy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between actigraphy and Lipsitz scoring system | Actigraphy and Lipsitz scoring system are realized at the same time twice a day | ninety minutes after feeding |