Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bronchopulmonary Dysplasia
- Prone Positioning
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: A list of study participants identified only study number, will be provided to a blinded outcomes assessor at 36 weeks post conceptional age. The respiratory support parameters of study participants will determine the primary outcome of moderate (Grade 2) or severe (Grade 3) BPD.Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 14 years
- Gender
- Both males and females
Description
We aim 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 respiratory device such as nasal cannula with flow rates greater than 2LPM receiving supplemental oxygen of greater than 21% for a...
We aim 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 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. Patients whose families consent to participation will be assigned via block randomization to usual care in which positioning and duration in each position is random per usual nursing routine OR Receive standardized scheduled daily prone positioning starting on day of life 7. As part of normal developmental care, most infants are evaluated and have care rendered (touch-time), if stable, and repositioned at set three-hour intervals to permit uninterrupted sleep and/or rest. The hands-off interval will be maintained throughout the study interval. Infants randomized to the standardized scheduled daily prone positioning will be placed in prone body position for a total of 6 hours daily, that is prone position for 3 hours, followed by supine positioning for 3 hrs, then placed in prone position for another 3-hour interval. Both infants randomized to standardized prone positioning and usual positioning will have a bedside card card identifying that the infant is a study participant and will serve as a way to document the number of times any infant enrolled in the study is placed in prone positioning even if not randomized to standardized prone positioning. Standardized daily positioning will occur for randomized patients until 36 weeks or discharge whichever is first. The primary outcome of moderate or severe BPD will be assigned by blinded study personnel based on respiratory support parameters on the day the infant is 36 weeks postconceptional age.
Tracking Information
- NCT #
- NCT04890158
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Alecia Thompson-Branch, MD Montefiore Medical Center Principal Investigator: Tomas Havranek Montefiore Medical Center
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