Trial Outcomes & Findings for ModPG3 Neo-Infant ISO 81060-2:2018 (NCT NCT05976425)
NCT ID: NCT05976425
Last Updated: 2026-02-23
Results Overview
Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020.
TERMINATED
7 participants
Day 1 (up to one hour)
2026-02-23
Participant Flow
One subject at the US site signed informed consent but failed screening prior to enrollment. Per protocol, enrollment occurs at assignment/start; therefore, Actual Enrollment and Started both equal 7 subjects.
Participant milestones
| Measure |
All Enrolled Subjects
All subjects who signed informed consent
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Blood Pressure Readings
n=7 Participants
All enrolled subjects eligible for study participation.
|
|---|---|
|
Age, Customized
< 29 days
|
0 Participants
n=7 Participants
|
|
Age, Customized
>= 29 days to < 3 years
|
7 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
7 participants
n=7 Participants
|
|
Arm Circumference of ≥3.3-15 cm
|
7 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 1 (up to one hour)Population: The study was terminated due to errors in the algorithm planned for data processing and analysis. A validated post-processing algorithm for the raw data files was never finalized; therefore, no analyzable blood pressure measurements exist and no participants were analyzed. No future analysis is planned, and no outcome data will ever be available for this study.
Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020.
Outcome measures
Outcome data not reported
Adverse Events
Blood Pressure Readings
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Baxter Clinical Trials Disclosure Call Center
Baxter Healthcare
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place