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.
Full Title of Study: “Standardized Prone Positioning Compared to Usual Positioning of Very Low Birth Weight Infants Receiving Respiratory Support and the Effect on Bronchopulmonary Dysplasia”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: June 2023
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 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 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.
- Other: Prone positioning for a total of 6 hours daily
- Prone postioning for 6 hours daily
Arms, Groups and Cohorts
- Experimental: 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 t osupine and back is to more reliably document possible changes in ventilation, oxygenation, other vital signs and respiratory support required.
- No Intervention: usual positioning
- Patients in the newrbon intensive care unit are physically handled usually every 3-4 hours. Those study participants who are radomly 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.
Clinical Trial Outcome Measures
- Moderate (Grade 2) or sever (grade 3) bronchopulmonary dysplasia
- Time Frame: as determined by respiratory support requirements at 36 weeks postconceptional age
- Severe (Grade 3) BPD: If an infant requires invasive positive pressure ventilation via an endotracheal or tracheostomy irrespective of the amount of FiO2. Moderate (Grade 2) BPD: If an infant requires nCPAP, NIPPV, HFNC, or NC > 2 liters per minute flow and receiving > 21% FiO2.
Participating in This Clinical Trial
- 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 a 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 Criteria:
- 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).
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 14 Weeks
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Montefiore Medical Center
- Provider of Information About this Clinical Study
- Overall Official(s)
- Alecia Thompson-Branch, MD, Principal Investigator, Montefiore Medical Center
- Tomas Havranek, Principal Investigator, Montefiore Medical Center
- Overall Contact(s)
- Alecia Thompson-Branch, MD, 718 904 4105, email@example.com
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