Impact of Extended CPAP on Bronchopulmonary Dysplasia

Sponsor

Christiana Care Health Services (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05547139

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Bronchopulmonary Dysplasia Prematurity	Other: Protocolized weaning of respiratory support	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Active Comparator: 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.	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).

Arm

Intervention/Treatment

No Intervention: 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.

Active Comparator: 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.

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).

Outcome Measures

Primary Outcome Measures

Time to reach 2L NC or room air [up to 3 months]
The primary outcome is time (in days) to reach 2L nasal cannula or room air

Secondary Outcome Measures

Compliance to protocol and balancing measures [up to 3 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Weeks to 30 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christiana Care Health Services, Inc.	Newark	Delaware	United States	19718

Sponsors and Collaborators

Christiana Care Health Services

Investigators

Principal Investigator: Kelley Z Kovatis, MD, Christiana Care Health Services, Inc
Principal Investigator: Anastasiya Latushko, Christiana Care Health Services, Inc