Neonatal Abstinence SyndromeACTINEONCT03977545
Actigraphy and Neonatal Abstinence Syndrome
A study testing Actigraphy in people with Neonatal Abstinence Syndrome, run by University Hospital, Caen at 1 site in France.
Trial summary
The aim of our study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome. Read more about this study
- Who is it for?
- Ages Up to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Actigraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborn > 32 weeks of gestation + 0 day
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen Univerity Hospital
Caen
Lecorps Elodie
About this study
Official title: Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome
The aim of our study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome.
Read the 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.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Actigraphy
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Newborn with risk of neonatal opioid abstinence syndrome | Other | The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 7 days Receives: Diagnostic Test: Actigraphy |
| Eutrophic term newborn | Other | The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days Receives: Diagnostic Test: Actigraphy |
| Term newborn with low birth weight | Other | The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days Receives: Diagnostic Test: Actigraphy |
| Eutrophic premature newborn | Other | The newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days Receives: Diagnostic Test: Actigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between actigraphy and Lipsitz scoring system
Actigraphy and Lipsitz scoring system are realized at the same time twice a day
Measured: ninety minutes after feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start23 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977545
- Sponsor's protocol ID
- 2018-A02290-55
- Acronym
- ACTINEO
- Status last verified
- Apr 2021
- First submitted
- 5 Jun 2019
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome
- ClinicalTrials.gov ID
- NCT03977545
- Acronym / sponsor ID
- ACTINEO / 2018-A02290-55
- Conditions
- Neonatal Abstinence Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Newborn with risk of neonatal opioid abstinence syndrome | Other | Diagnostic Test: ActigraphyThe newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 7 days |
| Eutrophic term newborn | Other | Diagnostic Test: ActigraphyThe newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days |
| Term newborn with low birth weight | Other | Diagnostic Test: ActigraphyThe newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days |
| Eutrophic premature newborn | Other | Diagnostic Test: ActigraphyThe newborns will have actigraphy during 30 minutes and Lipsitz scoring system twice a day during 2 days |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborn > 32 weeks of gestation + 0 day
Key exclusion criteria (6 listed)
- perinatal asphyxia
- 5- minute Apgar score < 7
- ante or post-natal brain injury diagnosis
- upper arm motor deficit
- hospitalization in intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActigraphyActigraphy 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. | Diagnostic test | Eutrophic premature newborn, Eutrophic term newborn, Newborn with risk of neonatal opioid abstinence syndrome, Term newborn with low birth weight |
Primary outcome
Correlation between actigraphy and Lipsitz scoring system
Time frame: ninety minutes after feeding
Actigraphy and Lipsitz scoring system are realized at the same time twice a day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actigraphy in people with Neonatal Abstinence Syndrome, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elodie LECORPS (0231272055, lecorps-e@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between actigraphy and Lipsitz scoring system (time frame: ninety minutes after feeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.