Health TrialsbyHealthPanel

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

ConditionsPreTerm NeonateRespiratory Distress Syndrome (RDS)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorRoyal Hospital For Women

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

All preterm infants (<33 weeks gestational age) from their 2nd week of life, receiving respiratory support via NCPAP

expected to stay on NCPAP for the following 5 days at the NICU, Royal Hospital for Women, Randwick, Sydney

provided written informed consent obtained from parents.

Disqualifiers

Neonates with previous abdominal surgery

Major congenital anomalies.

>33+0 weeks

Less than 1 week of age

Trial design

Design model

Crossover

Treatments tested in this trial

  • Neonatologist performed lung ultrasound

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: NPLUSActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mean ratio res/base (Resolution FiO2 / Baseline FiO2)

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.

Time frame
Resolution FiO2 assessed 1 hour after increased persisting (>10 min) FiO2 demand (absolute increase ≥ 10% over the FiO2 baseline)

Secondary outcomes

1

Mean FiO2 (within 48-hour blocks)

comparison of infants mean FiO2 in NPLUS vs. control period

Time frame
48 hours
2

FiO2 between T0 and T1

Time frame
Assessed 1 hour after increased persisting (>10 minutes) FiO2 demand (absolute increase ≥ 10% over the FiO2 baseline)
3

LUS between T0 and T1

Time frame
Assessed 1 hour after increased persisting (>10 minutes) FiO2 demand (absolute increase ≥ 10% over the FiO2 baseline)
4

Number of changes in ventilatory settings (PEEP)

Total number of changes from baseline PEEP settings during each study period.

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal Hospital For Women

Lead sponsor

Medical University of Graz

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: