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The PALS Study: Picturing Aeration with Lung Ultrasound after Surfactant

The PALS Study: Picturing Aeration with Lung Ultrasound in newborn infants receiving Surfactant

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001758897
Acronym
PALS study (Picturing Aeration with Lung Ultrasound after Surfactant)
Enrollment
40
Registered
2021-12-23
Start date
2022-01-10
Completion date
2023-06-30
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A medication called surfactant is commonly given to preterm newborn babies to help with their breathing. We are conducting a study using ultrasound to measure how quickly surfactant works to help babies who need help breathing. To do this, we will get ultrasound recordings of newborn baby’s lungs before and after surfactant is given. The purpose of this study is to use ultrasound to see how quickly surfactant works. We are using ultrasound of the lungs to monitor how the amount of air in the lungs changes after surfactant treatment. We hope to use the results from this study in the future to improve our care for babies that need surfactant. If you decide to participate, we will get ultrasound images of your baby’s lungs by gently placing an ultrasound probe on each side of your baby’s chest or back. The lung ultrasound assessments are brief, less than 1 minute. We will perform a total of four ultrasound assessments – one before your baby receives surfactant, and three in the two hours after surfactant is given. The assessments will not interfere with cuddles. If you don’t wish to take part, you don’t have to. Your baby will continue to receive the best possible care whether you take part or not. The decision to give surfactant, or the way that surfactant is being given, will be decided by the treating doctors and will not be changed by your participation in this study.

Interventions

This observational study aims to determine if surfactant administration (any dose / mechanism of administration) improves lung aeration, as assessed using lung ultrasound, in infants <72hrs old receiving their first dose of surfactant. A 3-second lung ultrasound, performed by a trained researcher, will be captured on the right and left side of the chest at each time point: - As soon as practicable before surfactant administration - As soon as practicable after surfactant administration (within

This observational study aims to determine if surfactant administration (any dose / mechanism of administration) improves lung aeration, as assessed using lung ultrasound, in infants <72hrs old receiving their first dose of surfactant. A 3-second lung ultrasound, performed by a trained researcher, will be captured on the right and left side of the chest at each time point: - As soon as practicable before surfactant administration - As soon as practicable after surfactant administration (within 5 minutes) - 10-20 minutes after surfactant administration - 1-2 hours after surfactant administration Each ultrasound will take approximately 1-2 minutes to obtain. At these time points, we will also collect clinical data including oxygen saturation, heart rate, respiratory rate, mode of ventilatory support, fraction of inspired oxygen, mean airway pressure, peak inspiratory pressure and positive end expiratory pressure. Where available, data from blood gas results will also be collected (pH, PaCO2, PaO2, BE, lactate). For each infant, we will also collect data on patient and maternal demographics (including gestational age, birth weight and gender), mode and timing of surfactant delivery (minimally invasive or via an endotracheal tube), time of birth, time since rupture of membranes, time of birth and patient outcomes (diagnosis, length of NICU admission, time to hospital discharge). Care for the infant will be dictated by Monash Newborn protocols. If the study is interfering with clinical care of the infant, the lung ultrasound exam will be immediately ceased and will not resume until the medical team feels the infant is stable enough for data collection to continue.

Sponsors

Monash Medical Centre
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
No minimum to 72 Hours
Healthy volunteers
No

Inclusion criteria

Infants less than or equal to 72 hours old receiving their first dose of surfactant are eligible for this study

Exclusion criteria

Infants will be excluded if they have a congenital abnormality that affects the lungs, like congenital diaphragmatic hernia. We will also exclude the infants of parents who cannot speak English (as verbal consent cannot be obtained).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026