HFNC and NCPAP in Extremely Preterm Infants

Guilherme Sant'Anna, MD

Status: Completed

Conditions: Extreme Prematurity

Treatments: Other: NCPAP; Other: HFNC

Study type: Interventional

Funder types: Other

Identifiers

NCT03649282

12-342-PED

Details and patient eligibility

About

To avoid or decrease the rate of complications in preterm infants after disconnection from a mechanical ventilation (extubation), non-invasive respiratory support is routinely used. While infants are most commonly extubated to nasal continuous positive airway pressure (NCPAP), high flow nasal cannula (HFNC) has emerged as an attractive alternative. However, research regarding the safety and efficacy of HFNC in the most extreme preterm infants is limited. Therefore, we hypothesize that immediately after extubation, measures of heart rate and respiratory behavior may be useful to investigate for any differences between HFNC and NCPAP.

Full description

Infants will be studied 30 min after extubation on both modes of support, provided in a random order. A transition period of 15 min between modes will be given. For each mode, recordings will be performed for 40 minutes. Analysis of these recordings will be done off line.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants with birth weight ≤ 1250 grams
• Infants that have been mechanically ventilated and undergoing their first elective extubation attempt

Exclusion criteria

• Major congenital anomalies, neuromuscular disease, hemodynamic instability (use of vasopressors or hypotension).
• Infants reintubated before initiation or during data collection.
• Parental/legal guardian consent not obtained.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

HFNC/NCPAP

Experimental group

Description:

HFNC will be provided for 45 minutes followed by NCPAP for 45 minutes. Cardiorespiratory signals including electrocardiogram (ECG), respiratory inductive plethysmography (RIP), oxygen saturation (SpO2) and Pulse rate will be recorded continuously during the interventions and analyzed offline.

Treatment:

Other: NCPAP

Other: HFNC

NCPAP/HFNC

Experimental group

Description:

NCPAP will be provided for 45 minutes followed by HFNC for 45 minutes. Cardiorespiratory signals including electrocardiogram (ECG), respiratory inductive plethysmography (RIP), oxygen saturation (SpO2) and Pulse rate will be recorded continuously during the interventions and analyzed offline.

Treatment:

Other: NCPAP

Other: HFNC