Status:
TERMINATED
Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
Lead Sponsor:
Montefiore Medical Center
Conditions:
Prone Positioning
Bronchopulmonary Dysplasia
Eligibility:
All Genders
7-14 years
Phase:
NA
Brief Summary
In this pilot study, the investigator team aims to evaluate whether standardized prone positioning compared to usual positioning improves moderate to severe bronchopulmonary dysplasia (BPD) rates as a...
Detailed Description
The investigator team aims to enroll and randomize infants born at less than 1500 grams at birth, who remain on positive pressure support for at least 7 days after birth AND/OR on any other respirator...
Eligibility Criteria
Inclusion
- infants born at less than 1500 grams at birth, who remain on positive pressure support for at least 7 days after birth AND/OR on any other respiratory device such as nasal cannula with flow rates greater than 2LPM receiving supplemental oxygen of greater than 21% for at least 7 days after birth. Positive pressure for the purposes of this study is defined as nasal cannula delivering a flow of 2 LPM or higher, continuous positive airway pressure (CPAP), non-invasive positive pressure ventilation or non-invasive mechanical ventilation (NIPPV/NIMV), as well infants who are intubated or have a tracheostomy for oxygenation and ventilation related to their lung disease, irrespective of the mode of ventilation.
Exclusion
- infants who were previously on room air without a respiratory device who were intubated for the purposes of surgery and were not receiving respiratory support as defined above prior, those intubated for other airway issues such as tracheal stenosis, broncheo- or tracheomalacia, etc and not for the management of BPD. Additional patients to be excluded include those with suspected or proven genetic or other major congenital anomalies that may impact cardiac and lung function including cardiac and lung anomalies, as well as those at the time of enrollment who require surgeries that will impact their ability to be placed in prone positioning (eg gastroschisis, omphalocele, etc).
Key Trial Info
Start Date :
December 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04890158
Start Date
December 7 2021
End Date
July 27 2022
Last Update
September 5 2024
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467