Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
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- STATUS
- Recruiting
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- End date
- Jun 21, 2024
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- participants needed
- 60
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- sponsor
- Montefiore Medical Center
Summary
We aim to evaluate in this pilot study whether standardized prone positioning compared to usual positioning improves moderate to severe BPD rates as assessed at 36 weeks post conceptional age in very low birth weight preterm infants with bronchopulmonary dysplasia.
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 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.
Details
| Condition | Prone Positioning, Bronchopulmonary Dysplasia |
|---|---|
| Treatment | Prone positioning for a total of 6 hours daily |
| Clinical Study Identifier | NCT04890158 |
| Sponsor | Montefiore Medical Center |
| Last Modified on | 21 March 2022 |
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