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Prone positioning for a total of 6 hours daily for Bronchopulmonary Dysplasia

N/A

Waitlist Available

Led By Tomas Havranek

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up as determined by respiratory support requirements at 36 weeks postconceptional age

Awards & highlights

Study Summary

This trial will compare whether infants with bronchopulmonary dysplasia have improved outcomes when positioned prone (face down) rather than in their usual position.

Eligible Conditions

Bronchopulmonary Dysplasia
Prone Positioning

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ as determined by respiratory support requirements at 36 weeks postconceptional age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~as determined by respiratory support requirements at 36 weeks postconceptional age

This trial's timeline: 3 weeks for screening, Varies for treatment, and as determined by respiratory support requirements at 36 weeks postconceptional age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prone positioning for a total of 6 hours daily by study protocolExperimental Treatment1 Intervention

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.

Group II: usual positioningActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor

441 Previous Clinical Trials

582,136 Total Patients Enrolled

Tomas HavranekPrincipal InvestigatorMontefiore Medical Center

Alecia Thompson-Branch, MDPrincipal InvestigatorMontefiore Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are eligible for this research project?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment is presently recruiting, with initial posting on December 7th 2021 and the most recent update on February 17th 2022. The trial needs 60 participants to be recruited from a single site."

Answered by AI

Is this research endeavor enrolling adults aged eighteen and over?

"Patients eligible for this trial are older than 7 Days and younger than 14 Weeks."

Answered by AI

Are there any vacancies for participants in this experiment?

"Confirmed. According to the clinicaltrials.gov record, this medical trial has been open for recruitment since December 7th 2021 and was last updated on February 17th 2022. Sixty individuals are being recruited from a single site."

Answered by AI

Are there any restrictions to who can participate in this research trial?

"This clinical trial is enrolling 60 infants with bronchopulmonary dysplasia, aged between 7 days and 14 weeks. Participants should meet the following criteria: birth weight under 1500 grams; remain on positive pressure support (nasal cannula delivering a flow of 2 LPM or higher, continuous positive airway pressure/CPAP, non-invasive positive pressure ventilation/NIPPV/NIMV) for at least seven days post-birth OR receive supplemental oxygen greater than 21% concentration via another respiratory device for no less than seven days after delivery. Intubated patients or those with tracheostomies who require"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04890158.