ACTINEO: Actigraphy and Neonatal Abstinence Syndrome

Sponsor

University Hospital, Caen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03977545

Collaborator

(none)

Enrollment

Location

Arms

35.3

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neonatal Abstinence Syndrome	Diagnostic Test: Actigraphy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome

Actual Study Start Date :

Jan 23, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Day

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caen Univerity Hospital	Caen		France

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT03977545

Other Study ID Numbers:

2018-A02290-55

First Posted:

Jun 6, 2019

Last Update Posted:

May 3, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neonatal Abstinence Syndrome

Syndrome

Study Results

No Results Posted as of May 3, 2021