Impact of Extended CPAP on Bronchopulmonary Dysplasia

Christiana Care Health Services

Status: Completed

Conditions: Prematurity; Bronchopulmonary Dysplasia

Treatments: Other: Protocolized weaning of respiratory support

Study type: Interventional

Funder types: Other

Identifiers

NCT05547139

605186

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 22 to 30 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Usual care group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Protocolized weaning of respiratory support