Impact of Extended CPAP on Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Impact of Extended CPAP Utilization on Bronchopulmonary Dysplasia in Extremely Premature Infants: A Pilot Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547139
• Other study ID #: 605186
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Christiana Care Health Services
• Contact: Kelley Z Kovatis, MD
• Phone: 302-301-2410
• Email: kelley.kovatis[@]christianacare.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Weeks to 30 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia
• Premature Birth
• Prematurity

Intervention

Other:
• 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).

Locations

Country	Name	City	State
United States	Christiana Care Health Services, Inc.	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compliance to protocol and balancing measures	compliance to intervention, medical team attitude towards intervention, death, pneumothorax after extubation, septal breakdown, necrotizing enterocolitis (NEC), number of failed wean off respiratory support attempts, duration of noninvasive respiratory support, failure to maintain non-invasive support, duration of Fi02 requirement >21%, need for systemic steroids, time to full enteral feeds, time to initiation of PO feeds, time to >75% PO feeds, length of stay, and growth velocity at discharge.	up to 3 months