Neonatologist-Performed Lung Ultrasound (NPLUS) to Guide Respiratory Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Neonatologist performed lung ultrasound: Neonatologist performed lung ultrasound is performed at T0 (reported persistent increased FiO2 demand) and T1 (one hour after T0). NPLUS may be able to detect loss of aeration and lead to more targeted interventions to improve lung aeration. A comprehensive lung ultrasound examination will take 5 minutes or less to perform and involves minimal handling for the patient.

Study summary

The goal of this cross-over clinical trial is to evaluate whether Neonatologist-Performed Lung Ultrasound (NPLUS) can be used in preterm babies on non-invasive breathing support to reduce the amount of oxygen they need. The main question it aims to answer is:

When a baby's oxygen requirement goes up, does NPLUS help to target interventions and reduce oxygen requirements?

Researchers will compare NPLUS to standard treatment.

Participants will:

Have a lung ultrasound performed whenever their oxygen requirement increases by more than 10%.

The ultrasound findings will be used to target interventions that aim to improve air entry in the lungs.

Each time this happens, the researchers will note what happens to the oxygen requirement afterwards.

Each participant will participate for five days. For the first two days, they will be randomized to either the NPLUS arm or the usual care arm.

There is then a 24 hour period of usual care. For the final two days, participants cross over to the other arm of the trial.

Eligibility

Primary outcome measure(s)

• Mean ratio res/base (Resolution FiO2 / Baseline FiO2) — Resolution FiO2 assessed 1 hour after increased persisting (>10 min) FiO2 demand (absolute increase ≥ 10% over the FiO2 baseline)
  For each subject a baseline FiO2 is established for the control and NPLUS periods. Each episode of increased persisting (\>10 min) FiO2 demand (absolute increase ≥ 10% over the FiO2 baseline) on non-invasive ventilation is defined as event. The aim of using NPLUS versus standard care (control) when managing an event is to reduce any increase from the subject's baseline in the resolution FiO2 level associated with the event. The ratio of the FiO2 at resolution of each event to baseline FiO2 is a continuous measurement which is 1 when the resolution FiO2 equals the subject's baseline value. A ratio of 1.2 means the resolution FiO2 for the event is 20% higher than the subject's baseline FiO2, a ratio \<1 indicates the resolution FiO2 for the event is less than the subject's baseline and so on.

Trial sites (1)

Other trials for the same condition