Bronchopulmonary Dysplasia, Prematurity
Conditions
Keywords
Bronchopulmonary dysplasia, Prematurity, High flow nasal cannula, Continuous positive airway pressure, NICU
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.
Interventions
OTHERProtocolized 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).
Sponsors
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Infants will be randomized to the usual care group or the protocol care group.
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 30 Weeks
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed