An observational study in Crying and Fussy Infant (Baby), sponsored by Danone Asia Pacific Holdings Pte, Ltd.. Completed at 1 site in United States. Open to participants aged Up to 15 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by Danone Asia Pacific Holdings Pte, Ltd. (part of Danone) · Observational
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
39 studies on the registry are indexed under Crying; 8 are open to participants now.
Browse Crying studies →Danone Asia Pacific Holdings Pte, Ltd. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy term infants of ≤15 weeks of age
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Infants:
Parents/Guardians of infants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of the LENA recorder to document crying and fussing
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
Time frame: 14 days
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
Time frame: 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
Time frame: 14 days
Using a parental questionnaire, investigate the usability of the e-diary and ClaimIt app interface
Using a parental questionnaire, investigate the usability of the e-diary and ClaimIt app interface
Time frame: 14 days
Using a parental questionnaire, investigate the usability of the LENA recording device
Using a parental questionnaire, investigate the usability of the LENA recording device
Time frame: 14 days
Explore possible correlations between crying and fussing behaviors and infant diet reports
Explore possible correlations between crying and fussing behaviors and infant diet reports
Time frame: 14 days
Plan to share: No
Ran from Nov 2017 to primary completion in May 2018, 6 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Danone Asia Pacific Holdings Pte, Ltd. →