Trial · NCT04487834
Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
NCT04487834, Phase 2, Completed, The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz; results first posted 2023-11-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Vivatlac Baby on Crying Behavior of Colicky Babies. Trials, record NCT04487834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04487834
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
- NCT number
- NCT04487834
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
- Conditions
- Infantile Colic
- Interventions
- Simethicone Solution, Vivatlac Baby
- First posted
- 2020-07-27
- Last updated
- 2023-11-22
- Results first posted
- 2023-11-22
- Limitations and caveats
A limitation of the study is the use of parental diaries to measure infants' crying behavior. Using paper diaries is not without problems. Nevertheless, it has been shown that paper diary recordings of common infant behavior can provide reasonably good estimates of durations, while behavioral frequencies may be underestimated. Another major limitation of the study is that medication was not blinded.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline | Three weeks | Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment. |
| Primary | Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent | Three weeks | Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment. |
| Primary | Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent | Three weeks | Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline | Three weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent | Three weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent | Three weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline | Simethicone Solution | 6 | Participants | ||
| Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline | Vivatlac Baby | 39 | Participants | ||
| Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent | Simethicone Solution | 13 | Participants | ||
| Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent | Vivatlac Baby | 46 | Participants | ||
| Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent | Simethicone Solution | 14 | Participants | ||
| Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent | Vivatlac Baby | 27 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Simethicone Solution | 33 | |
| Overall Study | STARTED | Multilac Baby | 54 | |
| Overall Study | COMPLETED | Simethicone Solution | 33 | |
| Overall Study | COMPLETED | Multilac Baby | 54 | |
| Overall Study | NOT COMPLETED | Simethicone Solution | 0 | |
| Overall Study | NOT COMPLETED | Multilac Baby | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Simethicone Solution | 0 | 33 |
| Total, all-cause mortality | Multilac Baby | 0 | 54 |
| Total, other adverse events | Simethicone Solution | 0 | 33 |
| Total, other adverse events | Multilac Baby | 0 | 54 |
| Total, serious adverse events | Simethicone Solution | 0 | 33 |
| Total, serious adverse events | Multilac Baby | 0 | 54 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Simethicone Solution vs Vivatlac Baby: Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent | Trial comparisons |
| Simethicone Solution vs Vivatlac Baby: Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent | Trial comparisons |
| Simethicone Solution vs Multilac Baby: deaths from any cause | Trial comparisons |
| Simethicone Solution vs Vivatlac Baby: Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline | Trial comparisons |
| Simethicone Solution vs Multilac Baby: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04487834
GET https://conductscience.org/api/trials/v1/NCT04487834/registered