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Preterm BirthPhase 3SUNSETNCT04315636

Surfactant Nebulization for the Early Aeration of the Preterm Lung

A Phase 3 study testing Surfactant nebulisation in people with Preterm Birth and Respiratory Distress Syndrome, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Respiratory distress syndrome is the most common cause of respiratory failure in preterm infants. Treatment consists of respiratory support and exogenous surfactant administration. Commonly, surfactant is administered via an endotracheal tube during mechanical ventilation. Read more about this study

Who is it for?
Ages Up to 3 minutes
What is being tested?
Surfactant nebulisation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSwitzerland
Study dates
19 Mar 2021to 16 Jan 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 3 minutes
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • inborn
  • gestational age at birth from 26 0/7 to 31 6/7 weeks
  • written informed consent

Who cannot join

  • severe congenital malformation adversely affecting surfactant nebulisation or life expectancy
  • a priori palliative care
  • genetically defined syndrome

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Neonatology, University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Surfactant Nebulization for the Early Aeration of the Preterm Lung: a Single Blinded, Parallel, Randomized Controlled Trial

Respiratory distress syndrome is the most common cause of respiratory failure in preterm infants. Treatment consists of respiratory support and exogenous surfactant administration. Commonly, surfactant is administered via an endotracheal tube during mechanical ventilation. However, mechanical ventilation is considered an important risk factor for developing bronchopulmonary dysplasia.

Surfactant nebulisation during noninvasive ventilation may offer an alternative method for surfactant administration and has been shown to be promising in terms of physiological as well as clinical changes. In preterm infants with respiratory distress syndrome, the effect of intratracheally administered surfactant on lung function during invasive ventilation has been studied extensively. However, the effect of early postnatal surfactant nebulization remains unclear.

Therefore, the investigators plan to conduct a randomized controlled trial in order to investigate the effect of surfactant nebulization immediately after birth on early postnatal lung volume and short-term respiratory stability.

Being tested
Surfactant nebulisation
Medical subject headings
Premature Birth, Respiratory Distress Syndrome, Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surfactant nebulisationDrug

    200 mg/kg body weight nebulised surfactant (Poractant alfa, Chiesi Farmaceutici SpA, Parma, Italy) via a customised vibrating membrane nebuliser (eFlow neonatal nebuliser system, PARI Pharma, Starnberg).

Study groups in NCT04315636
Study groupRoleWhat they receive
Surfactant nebulisationExperimentalThe experimental group will receive a positive end-expiratory pressure (PEEP, +/- noninvasive positive pressure ventilation) and nebulised surfactant via a customised vibrating membrane nebuliser. Nebulisation will commence with the first application of a PEEP and will continue for a maximum of 30 minutes.
Receives: Drug: Surfactant nebulisation
Standard careNo interventionThe control group will receive standard care (PEEP, +/- noninvasive positive pressure ventilation, without surfactant nebulisation).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EIT: End-expiratory lung impedance (EELI)

    Change in EELI using electrical impedance tomography (arbitrary units per kilogram)

    Measured: Between birth and 30 minutes of life.

Secondary outcomes (27)

  1. EIT: End-expiratory lung impedance (EELI)

    EELI using electrical impedance tomography (arbitrary units per kilogram).

    Measured: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age

  2. EIT: Regional ventilation distribution

    Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram).

    Measured: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.

  3. EIT: Tidal volumes

    Tidal volumes using electrical impedance tomography (arbitrary units per kilogram).

    Measured: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.

  4. EIT: Association between EELI losses and SpO2/FiO2 ratio.

    Association between the number of EELI losses >50% and the SpO2/FiO2 ratio.

    Measured: At 6, 12, and 24 hours of life.

  5. EIT: Association between EELI losses and need/level of respiratory support.

    Association between the number of EELI losses >50% and the need/level of respiratory support.

    Measured: At 6, 12, and 24 hours of life.

  6. Physiological: Heart rate

    Continuous recording of heart rate (beats per minute).

    Measured: For the first 30 minutes after birth, as well as at 6, 12, and 24 hours of life.

  7. Physiological: Oxygen saturation (SpO2)

    Continuous recording of SpO2 (%).

    Measured: For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.

  8. Physiological: Fraction of inspired oxygen

    Continuous recording of fraction of inspired oxygen.

    Measured: For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.

  9. Physiological: SpO2/FiO2 ratio

    SpO2/FiO2 ratio.

    Measured: At 6, 12, and 24 hours of life.

  10. Physiological: Body temperature

    Number of events with body temperature <36.5 or >37.5°C.

    Measured: In the delivery room.

  11. Respiratory: Peak inspiratory pressure (PIP)

    Continuous recording of PIP in the control group (cmH2O).

    Measured: During the first 30 minutes of life.

  12. Respiratory: Positive end-expiratory pressure (PEEP)

    Continuous recording of PEEP in the control group (cmH2O).

    Measured: During the first 30 minutes of life.

  13. Respiratory: Tidal volume (Vt)

    Continuous recording of Vt in the control group (cmH2O).

    Measured: During the first 30 minutes of life.

  14. Respiratory: PEEP (positive end-expiratory pressure)

    PEEP during noninvasive and invasive ventilation [mbar]

    Measured: At 6, 12, and 24 hours of life.

  15. Respiratory: PIP (peak inspiratory pressure)

    PIP during noninvasive and invasive ventilation [mbar]

    Measured: At 6, 12, and 24 hours of life.

  16. Respiratory: Respiratory rate

    Respiratory rate during noninvasive and invasive ventilation [breaths per minute]

    Measured: At 6, 12, and 24 hours of life.

  17. Clinical: Length and type of noninvasive respiratory support

    Total length of CPAP/NIPPV support assessed retrospectively using video recordings (min)

    Measured: During the first 30 minutes of life.

  18. Clinical: Total time on noninvasive and invasive respiratory support

    Total time on invasive and noninvasive respiratory support (days)

    Measured: Until 36 weeks postmenstrual age

  19. Clinical: Frequency and duration of facemask repositioning

    Frequency and duration of facemask repositioning assessed retrospectively using video recordings.

    Measured: During the first 30 minutes after birth.

  20. Clinical: Intubation

    Intubation rate (%)

    Measured: At 24 and 72 hours of life, at 7 days of life. Until 36 weeks postmenstrual age.

  21. Clinical: Time to first intubation

    Time to first intubation (days, minutes)

    Measured: From birth until 36 weeks postmenstrual age.

  22. Clinical: Number of episodes of desaturation and bradycardia

    Number of episodes of desaturation (SpO2 <80%) and bradycardia (<80 beats per minute)

    Measured: During the first 24 hours of life.

  23. Clinical: Bronchopulmonary dysplasia (BPD)

    BPD, maximum grade [number of cases]

    Measured: At 36 weeks postmenstrual age.

  24. Clinical: Intraventricular haemorrhage (IVH)

    IVH, maximum grade [number of cases]

    Measured: At 36 weeks postmenstrual age.

  25. Clinical: Retinopathy of prematurity (ROP)

    ROP, maximum grade [number of cases]

    Measured: At 36 weeks postmenstrual age.

  26. Clinical: Necrotizing enterocolitis (NEC)

    NEC, surgically treated [number of cases]

    Measured: At 36 weeks postmenstrual age.

  27. Clinical: Blood-culture positive sepsis

    Blood-culture positive sepsis [number of cases]

    Measured: At 36 weeks postmenstrual age.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2020
  2. Study start19 Mar 2021
  3. Primary completion1 Nov 2021
  4. Study completion16 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04315636
Sponsor's protocol ID
Sunset
Acronym
SUNSET
Status last verified
Jul 2024
First submitted
6 Mar 2020
Last updated
8 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Minocchieri S, Berry CA, Pillow JJ; CureNeb Study Team. Nebulised surfactant to reduce severity of respiratory distress: a blinded, parallel, randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2019 May;104(3):F313-F319. doi: 10.1136/archdischild-2018-315051. Epub 2018 Jul 26.

    PubMed 30049729

  • Gaertner VD, Buchler VL, Waldmann A, Bassler D, Ruegger CM. Deciphering Mechanisms of Respiratory Fetal-to-Neonatal Transition in Very Preterm Infants. Am J Respir Crit Care Med. 2024 Mar 15;209(6):738-747. doi: 10.1164/rccm.202306-1021OC.

    PubMed 38032260

  • Gaertner VD, Minocchieri S, Waldmann AD, Muhlbacher T, Bassler D, Ruegger CM; SUNSET study group. Prophylactic surfactant nebulisation for the early aeration of the preterm lung: a randomised clinical trial. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):217-223. doi: 10.1136/archdischild-2022-324519. Epub 2022 Nov 24.

    PubMed 36424125

  • Gaertner VD, Waldmann AD, Bassler D, Hooper SB, Ruegger CM. Intrapulmonary Volume Changes during Hiccups versus Spontaneous Breaths in a Preterm Infant. Neonatology. 2022;119(4):525-529. doi: 10.1159/000524194. Epub 2022 Apr 8.

    PubMed 35398844

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Surfactant nebulisation in people with Preterm Birth and Respiratory Distress Syndrome, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EIT: End-expiratory lung impedance (EELI) (time frame: Between birth and 30 minutes of life.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04315636, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.

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