Impact of Extended CPAP on Bronchopulmonary Dysplasia

NCT ID: NCT05547139

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2024-07-31

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).

Detailed Description

There are two ways to help premature babies breathe. Both HFNC and CPAP are commonly used in our NICU. CPAP, which helps your baby breathe without a tube in their windpipe (intubation or ventilator), delivers oxygen and air by pressure through either small prongs in the nose or a nose mask, keeping your baby's airways open. HFNC provides heated and humidified oxygen and air by small prongs in the nose that does not use high pressure to the airways. Our goals are to reduce long term complications such as lung disease of prematurity, also called Bronchopulmonary Dysplasia (BPD). BPD causes "lung damage/scarring, need for a ventilator or oxygen, brain/neurological impairment etc. In recent years, HFNC has become a common choice for care. There is no clear agreement in previous research which way may be best to reduce BPD.

Conditions

Bronchopulmonary Dysplasia; Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Usual care group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Protocol care group

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.

Group Type: ACTIVE_COMPARATOR

Protocolized weaning of respiratory support

Intervention Type: 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).

Interventions

Protocolized weaning of respiratory support

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 22 Weeks
• Maximum Eligible Age: 30 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelley Z Kovatis, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services, Inc

Anastasiya Latushko

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services, Inc

Locations

Christiana Care Health Services, Inc.

Newark, Delaware, United States

Countries

United States

Other Identifiers

605186

Identifier Type: -

Identifier Source: org_study_id