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

NCT04890158 | Terminated Results DMC

• 1 other identifier: 2021-13059
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Prone Positioning; Bronchopulmonary Dysplasia

Keywords

prone positioning; bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• 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.

  as determined by respiratory support requirements at 36 weeks postconceptional age

Study Arms (2)

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.

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.

Interventions

Prone positioning for a total of 6 hours daily OTHER

Prone positioning for 6 hours daily

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

Eligibility Criteria

• Age: 7 Days - 14 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Alecia Thompson-Branch
• Organization: Montefiore Medical Center

alethomp@montefiore.org

718-904-4105

Study Officials

• Alecia Thompson-Branch, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: December 7, 2021
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)