Impact of Extended CPAP on Bronchopulmonary Dysplasia

Christiana Care Health Services20 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Bronchopulmonary Dysplasia Prematurity

Interventions

Protocolized weaning of respiratory supportOTHER

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).

Eligibility

Sex: ALLMin age: 22 WeeksMax age: 30 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Christiana Care Health Services, Inc.

Newark, Delaware, United States

Outcomes

Primary Outcomes

Time to reach 2L NC or room air

The primary outcome is time (in days) to reach 2L nasal cannula or room air

Time frame: up to 3 months

Secondary Outcomes

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.

Time frame: up to 3 months

Data from ClinicalTrials.gov

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