CryingLENUSNCT03390348
An In-home Observational Study to Compare Infant Crying and Fussing Parameters Documented by the LENA Recorder With Those Documented Via Parental E-diaries
An observational study of Crying and Fussy Infant (Baby), run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in United States.
Trial summary
This is a in-home observational study of 12 healthy term infants of ≤15 weeks of age to compare infant crying and fussing parameters documented by the LENA recorder with those documented via parental e-diaries Read more about this study
- Who is it for?
- Ages Up to 15 weeksHealthy volunteers can take part
- Conditions the study is for
- Crying, Fussy Infant (Baby)
- What is being tested?
- LENA Recorder
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2017to 22 May 2018
- Phase
- Observational
- 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 15 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy term infants of ≤15 weeks of age
Who may be able to join
- Healthy term infants, age ≤15 weeks
- Singleton infants (≥37 and ≤42 weeks gestation)
- Birth weight within normal range for gender and gestational age
- Informed consent from parent or legal guardian whose age is ≥18 years old
- Live in a household with reliable electronic communication capability (e.g. smart phone, computer, internet access)
- Infants who are breastfed and/or are consuming any commercial infant formula as a major nutrient source
- Parent's/guardian's English literacy sufficient to follow instructions and complete forms
Who cannot join
- Infants:
- Currently or within last 30 days prior to screening, participation in any other investigational studies
- Known to have current or previous illness/condition which could interfere with the study outcome, as per Investigator's clinical judgment
- Parents/Guardians of infants:
- Known to have a significant medical condition (including during pregnancy) that might interfere with the study, as per Investigator's clinical judgment
- Inability to comply with study protocol, as per the Investigator's judgement
Trial locations and contacts
1 site in 1 country.
About this study
This is a in-home observational study of 12 healthy term infants of ≤15 weeks of age to compare infant crying and fussing parameters documented by the LENA recorder with those documented via parental e-diaries
- Conditions
- Crying, Fussy Infant (Baby)
- Being tested
- LENA Recorder
- Medical subject headings
- Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LENA RecorderDevice
Use of the LENA recorder to document crying and fussing
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries
Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries
Measured: 14 days
Secondary outcomes (2)
Quantification of inconsolable and unexplainable crying and fussing times based on parental e-diaries
Quantification of inconsolable and unexplainable crying and fussing times based on parental e-diaries
Measured: 14 days
Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder
Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start22 Nov 2017
- Primary completion22 May 2018
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CryingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LENA Foundation, ObvioHealth
- Responsible party
- Sponsor
- Investigators
- Parth Shah, MD, Principal investigator, Obvio Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390348
- Sponsor's protocol ID
- OBVIO-DAN-001
- Other IDs
- EBB17GC16811
- Acronym
- LENUS
- Status last verified
- Aug 2018
- First submitted
- 27 Dec 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dykstra JR, Sabatos-Devito MG, Irvin DW, Boyd BA, Hume KA, Odom SL. Using the Language Environment Analysis (LENA) system in preschool classrooms with children with autism spectrum disorders. Autism. 2013 Sep;17(5):582-94. doi: 10.1177/1362361312446206. Epub 2012 Jul 2.
PubMed 22751753Canault M, Le Normand MT, Foudil S, Loundon N, Thai-Van H. Reliability of the Language ENvironment Analysis system (LENA) in European French. Behav Res Methods. 2016 Sep;48(3):1109-24. doi: 10.3758/s13428-015-0634-8.
PubMed 26174716
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-home Observational Study to Compare Infant Crying and Fussing Parameters Documented by the LENA Recorder With Those Documented Via Parental E-diaries
- ClinicalTrials.gov ID
- NCT03390348
- Acronym / sponsor ID
- LENUS / OBVIO-DAN-001
- Conditions
- Crying, Fussy Infant (Baby)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- LENA Foundation, ObvioHealth
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 4 Jan 2018 (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.
This is a in-home observational study of 12 healthy term infants of ≤15 weeks of age to compare infant crying and fussing parameters documented by the LENA recorder with those documented via parental e-diaries
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 15 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy term infants of ≤15 weeks of age
Key inclusion criteria (7 listed)
- Healthy term infants, age ≤15 weeks
- Singleton infants (≥37 and ≤42 weeks gestation)
- Birth weight within normal range for gender and gestational age
- Informed consent from parent or legal guardian whose age is ≥18 years old
- Live in a household with reliable electronic communication capability (e.g. smart phone, computer, internet access)
Key exclusion criteria (6 listed)
- Currently or within last 30 days prior to screening, participation in any other investigational studies
- Known to have current or previous illness/condition which could interfere with the study outcome, as per Investigator's clinical judgment
- Known to have a significant medical condition (including during pregnancy) that might interfere with the study, as per Investigator's clinical judgment
- Inability to comply with study protocol, as per the Investigator's judgement
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 |
|---|---|---|
| LENA RecorderUse of the LENA recorder to document crying and fussing | Device | – |
Primary outcome
Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries
Time frame: 14 days
Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries
2 secondary outcomes
Quantification of inconsolable and unexplainable crying and fussing times based on parental e-diaries
Time frame: 14 days
Quantification of inconsolable and unexplainable crying and fussing times detected by the LENA recorder
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Background: PubMed 22751753Dykstra JR, Sabatos-Devito MG, Irvin DW, Boyd BA, Hume KA, Odom SL. Using the Language Environment Analysis (LENA) system in preschool classrooms with children with autism spectrum disorders. Autism. 2013 Sep;17(5):582-94. doi: 10.1177/1362361312446206. Epub 2012 Jul 2.
- Results publication: PubMed 26174716Canault M, Le Normand MT, Foudil S, Loundon N, Thai-Van H. Reliability of the Language ENvironment Analysis system (LENA) in European French. Behav Res Methods. 2016 Sep;48(3):1109-24. doi: 10.3758/s13428-015-0634-8.
- Individual participant dataSharing planned: No
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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.
Parth Shah, MD principal investigator
Obvio Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crying and Fussy Infant (Baby), run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 17 Aug 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the crying and fussing documented by the LENA recorder with the crying and fussing documented in the parental e-diaries (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03390348, which also lists 2 linked publications.
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 17 Aug 2018.