Impact of Extended CPAP on Bronchopulmonary Dysplasia

Not Applicable

Completed

• Conditions: Bronchopulmonary Dysplasia; Prematurity
• Interventions: Other: Protocolized weaning of respiratory support

• Registration Number: NCT05547139
• Lead Sponsor: Christiana Care Health Services

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.

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-21
• Study Start: 2022-10-10
• Primary Completion: 2024-05-31
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocol care group	Protocolized weaning of respiratory support	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Christiana Care Health Services, Inc.; 🇺🇸 Newark, Delaware, United States