Impact of Extended CPAP on Bronchopulmonary Dysplasia

NCT05547139 | Completed

• 1 other identifier: 605186
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately 2 pounds and 12 ounces) will decrease their degree of lung disease as compared to weaning their respiratory support to HFNC (high flow nasal cannula).

Conditions

Bronchopulmonary Dysplasia; Prematurity

Keywords

Bronchopulmonary dysplasia; Prematurity; High flow nasal cannula; Continuous positive airway pressure; NICU

Outcome Measures

Primary Outcomes (1)

• Time to reach 2L NC or room air

  The primary outcome is time (in days) to reach 2L nasal cannula or room air

  up to 3 months

Secondary Outcomes (1)

• Compliance to protocol and balancing measures

  up to 3 months

Study Arms (2)

Usual care group

NO INTERVENTION

Infants randomized to this group will receive the present standard of care for weaning respiratory support. This means the attending provider will decide when each infant is ready to be changed from CPAP to nasal cannula and the nasal cannula will be weaned according to an existing unit protocol.

Protocol care group

ACTIVE COMPARATOR

Infants randomized to this group will remain on CPAP until they are at least 32 weeks corrected gestational age or 1250g. At that point, if they meet a set of criteria, they will be transitioned to either 2L nasal cannula if they require supplemental oxygen or room air.

Other: Protocolized weaning of respiratory support

Interventions

Protocolized weaning of respiratory support OTHER

The protocolized weaning aims to keep babies on CPAP for a longer period of time and will measure how long it takes babies to wean to 2L nasal cannula support or come off all support (room air, RA).

Protocol care group

Eligibility Criteria

• Age: 22 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• babies born at \<30 weeks' gestation
• babies who are extubated to non-invasive ventilation by 32 weeks postmenstrual age

You may not qualify if:

• babies born at \<30 weeks' gestation
• requiring less than 2L NC at birth or
• those who are extubated after 32.0 weeks' postmenstrual age
• congenital anomalies
• skeletal disorders
• neuromuscular disorders
• genetic syndromes

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

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; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kelley Z Kovatis, MD

  Christiana Care Health Services, Inc

  PRINCIPAL INVESTIGATOR

• Anastasiya Latushko

  Christiana Care Health Services, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Infants will be randomized to the usual care group or the protocol care group.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 21, 2022
• Study Start: October 10, 2022
• Primary Completion: May 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)