Trial Outcomes & Findings for Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants. (NCT NCT04890158)
NCT ID: NCT04890158
Last Updated: 2024-09-05
Results Overview
The number of infants with either Moderate or Severe Bronchopulmonary Dysplasia (BPD) will be determined per study arm. Moderate and Severe BPD will be defined as follows: Moderate (Grade 2) BPD: If an infant requires nCPAP, NIPPV, HFNC, or NC \> 2 liters per minute flow and receiving \> 21% FiO2. Severe (Grade 3) BPD: If an infant requires invasive positive pressure ventilation via an endotracheal or tracheostomy irrespective of the amount of FiO2.
TERMINATED
NA
1 participants
as determined by respiratory support requirements at 36 weeks postconceptional age
2024-09-05
Participant Flow
Participant milestones
| Measure |
Prone Positioning for a Total of 6 Hours Daily by Study Protocol
Patients will be positioned prone for 3 hours then placed supine for 3 hours then prone again for 3 additional hours. The change in position from prone to supine and back is to more reliably document possible changes in ventilation, oxygenation, other vital signs and respiratory support required.
Prone positioning for a total of 6 hours daily: Prone positioning for 6 hours daily
|
Usual Positioning
Patients in the newborn intensive care unit are physically handled usually every 3-4 hours. Those study participants who are randomly assigned to "usual position" may rest in a variety of positions in any order based on nursing or perceived patient preference. Positions may include supine, right lateral, left lateral, and prone as well.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prone Positioning for a Total of 6 Hours Daily by Study Protocol
n=1 Participants
Patients will be positioned prone for 3 hours then placed supine for 3 hours then prone again for 3 additional hours. The change in position from prone to supine and back is to more reliably document possible changes in ventilation, oxygenation, other vital signs and respiratory support required.
Prone positioning for a total of 6 hours daily: Prone positioning for 6 hours daily
|
Usual Positioning
Patients in the newborn intensive care unit are physically handled usually every 3-4 hours. Those study participants who are randomly assigned to "usual position" may rest in a variety of positions in any order based on nursing or perceived patient preference. Positions may include supine, right lateral, left lateral, and prone as well.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Approximately 27 weeks
|
1 Participants
n=1 Participants
|
0 Participants
|
1 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
0 Participants
|
1 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
—
|
1 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: as determined by respiratory support requirements at 36 weeks postconceptional agePopulation: The study was terminated early and Primary Outcome Measure data was not collected and/or analyzed for this study.
The number of infants with either Moderate or Severe Bronchopulmonary Dysplasia (BPD) will be determined per study arm. Moderate and Severe BPD will be defined as follows: Moderate (Grade 2) BPD: If an infant requires nCPAP, NIPPV, HFNC, or NC \> 2 liters per minute flow and receiving \> 21% FiO2. Severe (Grade 3) BPD: If an infant requires invasive positive pressure ventilation via an endotracheal or tracheostomy irrespective of the amount of FiO2.
Outcome measures
Outcome data not reported
Adverse Events
Prone Positioning for a Total of 6 Hours Daily by Study Protocol
Usual Positioning
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place