Prone PositioningNCT04890158
Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
A study testing Prone positioning for a total of 6 hours daily in people with Prone Positioning and Bronchopulmonary Dysplasia, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 14 weeks
- Conditions the study is for
- Prone Positioning, Bronchopulmonary Dysplasia
- What is being tested?
- Prone positioning for a total of 6 hours daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 14 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Standardized Prone Positioning Compared to Usual Positioning of Very Low Birth Weight Infants Receiving Respiratory Support and the Effect on Bronchopulmonary Dysplasia
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.
Read the 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.
- Conditions
- Prone Positioning, Bronchopulmonary Dysplasia
- Being tested
- Prone positioning for a total of 6 hours daily
- Keywords
- prone positioning, bronchopulmonary dysplasia
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positioning for a total of 6 hours dailyOther
Prone positioning for 6 hours daily
| Study group | Role | What they receive |
|---|---|---|
| Prone positioning for a total of 6 hours daily by study protocol | Experimental | 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. Receives: Other: Prone positioning for a total of 6 hours daily |
| usual positioning | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate (Grade 2) or Severe (Grade 3) Bronchopulmonary Dysplasia
The number of infants with either Moderate or Severe Bronchopulmonary Dysplasia (BPD) will be determined per study arm. Moderate and Severe BPD will be defined as follows:
Moderate (Grade 2) BPD: If an infant requires nCPAP, NIPPV, HFNC, or NC > 2 liters per minute flow and receiving > 21% FiO2.
Severe (Grade 3) BPD: If an infant requires invasive positive pressure ventilation via an endotracheal or tracheostomy irrespective of the amount of FiO2.
Measured: as determined by respiratory support requirements at 36 weeks postconceptional age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start7 Dec 2021
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Why it stopped: Protocol review had expired and the study had previously been Suspended. There was no funding to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prone PositioningStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alecia Thompson-Branch, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890158
- Sponsor's protocol ID
- 2021-13059
- Status last verified
- Aug 2024
- First submitted
- 12 May 2021
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Prone Positioning Compared to Usual Positioning of Very Low Birth Weight Infants Receiving Respiratory Support and the Effect on Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT04890158
- Acronym / sponsor ID
- 2021-13059
- Conditions
- Prone Positioning, Bronchopulmonary Dysplasia
- Keywords
- prone positioning, bronchopulmonary dysplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol review had expired and the study had previously been Suspended. There was no funding to continue the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone positioning for a total of 6 hours daily by study protocol | Experimental | Other: Prone positioning for a total of 6 hours dailyPatients 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. |
| usual positioning | No intervention | –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. |
Who may qualify
- Ages
- 7 days to 14 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone positioning for a total of 6 hours dailyProne positioning for 6 hours daily | Other | Prone positioning for a total of 6 hours daily by study protocol |
Primary outcome
Moderate (Grade 2) or Severe (Grade 3) Bronchopulmonary Dysplasia
Time frame: as determined by respiratory support requirements at 36 weeks postconceptional age
The number of infants with either Moderate or Severe Bronchopulmonary Dysplasia (BPD) will be determined per study arm. Moderate and Severe BPD will be defined as follows: Moderate (Grade 2) BPD: If an infant requires nCPAP, NIPPV, HFNC, or NC > 2 liters per minute flow and receiving > 21% FiO2. Severe (Grade 3) BPD: If an infant requires invasive positive pressure ventilation via an endotracheal or tracheostomy irrespective of the amount of FiO2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Prone Positioning
Recruiting
Hemodynamic Effects of Surgical Position in Prone vs. Supine Percutaneous Nephrolithotomy
Percutaneous Nephrolithotomy (PCNL), Surgical Positioning
Recruiting
Pressure Sore Prevention Strategy for the Prone Position
Pressure Ulcers Prevention in Prone Positioning in Intensive Care
RecruitingObservational study
Physiological Studies in the Prone Position in Patients With ARDS
Acute Respiratory Distress Syndrome, Mechanical Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alecia Thompson-Branch, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone positioning for a total of 6 hours daily in people with Prone Positioning and Bronchopulmonary Dysplasia, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate (Grade 2) or Severe (Grade 3) Bronchopulmonary Dysplasia (time frame: as determined by respiratory support requirements at 36 weeks postconceptional age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.