NCT04890158

Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.

Standardized Prone Positioning Compared to Usual Positioning of Very Low Birth Weight Infants Receiving Respiratory Support and the Effect on Bronchopulmonary Dysplasia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 7 Days – 14 Weeks
• Healthy volunteers: Not accepted

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 assessed at 36 weeks post conceptional age in very low birth weight preterm infants with bronchopulmonary dysplasia.

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 respiratory device such as nasal cannula with flow rates greater than 2 liters per minute (LPM) 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 1. usual care in which positioning and duration in each position is random per usual nursing routine OR 2. 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 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.

Conditions

• Prone Positioning
• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
OTHER	Prone positioning for a total of 6 hours daily	Prone positioning for 6 hours daily

Timeline

• Start date: 2021-12-07
• Primary completion: 2022-07-27
• Completion: 2022-07-27
• First posted: 2021-05-18
• Last updated: 2024-09-05
• Results posted: 2024-09-05

Locations

1 site across 1 country: United States