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

Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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

        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.
    

Study Type

Interventional

Primary Outcome

Moderate (Grade 2) or sever (grade 3) bronchopulmonary dysplasia

Condition

Prone Positioning

Intervention

Prone positioning for a total of 6 hours daily

Study Arms / Comparison Groups

 Prone positioning for a total of 6 hours daily by study protocol

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

60

Start Date

August 2021

Completion Date

June 2024

Primary Completion Date

June 2023

Eligibility Criteria

        Inclusion Criteria:

          -  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

All

Ages

N/A - 14 Weeks

Accepts Healthy Volunteers

No

Contacts

Alecia Thompson-Branch, MD, 718 904 4105, [email protected]

NCT ID

NCT04890158

Organization ID

2021-13059

Responsible Party

Sponsor

Study Sponsor

Montefiore Medical Center

Study Sponsor

Alecia Thompson-Branch, MD, Principal Investigator, Montefiore Medical Center

Verification Date

July 2021