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

Primary Purpose

Prone Positioning, Bronchopulmonary Dysplasia

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prone positioning for a total of 6 hours daily
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prone Positioning focused on measuring prone positioning, bronchopulmonary dysplasia

Eligibility Criteria

7 Days - 14 Weeks (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

usual positioning

Arm 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 to supine and back is to more reliably document possible changes in ventilation, oxygenation, other vital signs and respiratory support required.

Patients in the newborn intensive care unit are physically handled usually every 3-4 hours. Those study participants who are randomly 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2021
Last Updated
March 1, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04890158
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
Study suspended. Protocol would need to be re-approved by the Einstein IRB
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prone Positioning, Bronchopulmonary Dysplasia
Keywords
prone positioning, bronchopulmonary dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prone positioning for a total of 6 hours daily by study protocol
Arm Type
Experimental
Arm 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 to supine and back is to more reliably document possible changes in ventilation, oxygenation, other vital signs and respiratory support required.
Arm Title
usual positioning
Arm Type
No Intervention
Arm Description
Patients in the newborn intensive care unit are physically handled usually every 3-4 hours. Those study participants who are randomly 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.
Intervention Type
Other
Intervention Name(s)
Prone positioning for a total of 6 hours daily
Intervention Description
Prone positioning for 6 hours daily
Primary Outcome Measure Information:
Title
Moderate (Grade 2) or sever (grade 3) bronchopulmonary dysplasia
Description
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.
Time Frame
as determined by respiratory support requirements at 36 weeks postconceptional age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
14 Weeks
Accepts Healthy Volunteers
No
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 as 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alecia Thompson-Branch, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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