Trial · NCT07894445
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Daily total crying and fussing time at day 7 | 7 days after initiation of intervention | Total infant crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
| Secondary | Change in daily total crying and fussing time from baseline to day 7 | At Day 0 and at day 7 of intervention | Total infant crying duration and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
| Secondary | Change in daily total crying and fussing time from baseline to every day during 21days of treatment | During 21 days of treatment | Total infant crying duration and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
| Secondary | Proportion of responder patients assessed using a parent-completed daily sleep diary (Baby's Day Diary) | During the first 21 days of treatment | Proportion of patients responders to the treatment, defined as the number of infants with ≥50% reduction in crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
| Secondary | Sleeping time | During the first 21 days of treatment | Total infant sleep duration, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
| Secondary | PedsQL Family Impact Module | During 21 days of treatment | Changes in PedsQL Family Impact Module range 0-100 (with higher scores reflecting better functioning) from baseline to Days 7 and 21 |
| Secondary | Maternal Edinburgh Postnatal Depression Scale score | During 21 days of treatment | Changes in Maternal Edinburgh Postnatal Depression Scale score evaluation Total score range: 0 to 30 (higher score on the Edinburgh Postnatal Depression Scale (EPDS) indicates a greater severity of symptoms) from baseline to Days 7 and 21 |
| Secondary | Number of participants experiencing adverse events and serious adverse events. | From initiation of the intervention (Day 1) through Day 28.Adverse events, serious adverse events | Number of participants experiencing at least one adverse event (AE) or serious adverse event (SAE) during the study. Events will be recorded and characterized according to type, severity, seriousness, and relationship to the study intervention. |
| Secondary | Body temperature | At day 0 and 21 | body temperature (°C) |
| Secondary | Heart rate | At day 0 and 21 | heart rate (BPM) |
| Secondary | Respiratory rate | At day 0 and 21 | Respiratory rate/minute |
| Secondary | Blood pressure | At day 0 and 21 | blood pressure (mmHg) |
| Secondary | Height | At day 0 and 21 | Height in cm |
| Secondary | Weight | At day 0 and 21 | Weight in Kg |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07894445/registered