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Surfactant Nebulization for the Early Aeration of the Preterm Lung (SUNSET)

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ClinicalTrials.gov Identifier: NCT04315636
Recruitment Status : Completed
First Posted : March 19, 2020
Last Update Posted : November 22, 2022
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Preterm Birth Respiratory Distress Syndrome Surfactant Deficiency Syndrome Neonatal Drug: Surfactant nebulisation Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Surfactant Nebulization for the Early Aeration of the Preterm Lung: a Single Blinded, Parallel, Randomized Controlled Trial
Actual Study Start Date : March 19, 2021
Actual Primary Completion Date : November 1, 2021
Actual Study Completion Date : January 16, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Surfactant nebulisation
The 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.
 Drug: Surfactant nebulisation
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).
No Intervention: Standard care
The control group will receive standard care (PEEP, +/- noninvasive positive pressure ventilation, without surfactant nebulisation).


Outcome Measures
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Primary Outcome Measures :
  1. EIT: End-expiratory lung impedance (EELI) [ Time Frame: Between birth and 30 minutes of life. ]
    Change in EELI using electrical impedance tomography (arbitrary units per kilogram)


Secondary Outcome Measures :
  1. EIT: End-expiratory lung impedance (EELI) [ Time Frame: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age ]
    EELI using electrical impedance tomography (arbitrary units per kilogram).

  2. EIT: Regional ventilation distribution [ Time Frame: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age. ]
    Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram).

  3. EIT: Tidal volumes [ Time Frame: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age. ]
    Tidal volumes using electrical impedance tomography (arbitrary units per kilogram).

  4. EIT: Association between EELI losses and SpO2/FiO2 ratio. [ Time Frame: At 6, 12, and 24 hours of life. ]
    Association between the number of EELI losses >50% and the SpO2/FiO2 ratio.

  5. EIT: Association between EELI losses and need/level of respiratory support. [ Time Frame: At 6, 12, and 24 hours of life. ]
    Association between the number of EELI losses >50% and the need/level of respiratory support.

  6. Physiological: Heart rate [ Time Frame: For the first 30 minutes after birth, as well as at 6, 12, and 24 hours of life. ]
    Continuous recording of heart rate (beats per minute).

  7. Physiological: Oxygen saturation (SpO2) [ Time Frame: For the first 30 minutes after birth, and at 6, 12, and 24 hours of life. ]
    Continuous recording of SpO2 (%).

  8. Physiological: Fraction of inspired oxygen [ Time Frame: For the first 30 minutes after birth, and at 6, 12, and 24 hours of life. ]
    Continuous recording of fraction of inspired oxygen.

  9. Physiological: SpO2/FiO2 ratio [ Time Frame: At 6, 12, and 24 hours of life. ]
    SpO2/FiO2 ratio.

  10. Physiological: Body temperature [ Time Frame: In the delivery room. ]
    Number of events with body temperature <36.5 or >37.5°C.

  11. Respiratory: Peak inspiratory pressure (PIP) [ Time Frame: During the first 30 minutes of life. ]
    Continuous recording of PIP in the control group (cmH2O).

  12. Respiratory: Positive end-expiratory pressure (PEEP) [ Time Frame: During the first 30 minutes of life. ]
    Continuous recording of PEEP in the control group (cmH2O).

  13. Respiratory: Tidal volume (Vt) [ Time Frame: During the first 30 minutes of life. ]
    Continuous recording of Vt in the control group (cmH2O).

  14. Respiratory: PEEP (positive end-expiratory pressure) [ Time Frame: At 6, 12, and 24 hours of life. ]
    PEEP during noninvasive and invasive ventilation [mbar]

  15. Respiratory: PIP (peak inspiratory pressure) [ Time Frame: At 6, 12, and 24 hours of life. ]
    PIP during noninvasive and invasive ventilation [mbar]

  16. Respiratory: Respiratory rate [ Time Frame: At 6, 12, and 24 hours of life. ]
    Respiratory rate during noninvasive and invasive ventilation [breaths per minute]

  17. Clinical: Length and type of noninvasive respiratory support [ Time Frame: During the first 30 minutes of life. ]
    Total length of CPAP/NIPPV support assessed retrospectively using video recordings (min)

  18. Clinical: Total time on noninvasive and invasive respiratory support [ Time Frame: Until 36 weeks postmenstrual age ]
    Total time on invasive and noninvasive respiratory support (days)

  19. Clinical: Frequency and duration of facemask repositioning [ Time Frame: During the first 30 minutes after birth. ]
    Frequency and duration of facemask repositioning assessed retrospectively using video recordings.

  20. Clinical: Intubation [ Time Frame: At 24 and 72 hours of life, at 7 days of life. Until 36 weeks postmenstrual age. ]
    Intubation rate (%)

  21. Clinical: Time to first intubation [ Time Frame: From birth until 36 weeks postmenstrual age. ]
    Time to first intubation (days, minutes)

  22. Clinical: Number of episodes of desaturation and bradycardia [ Time Frame: During the first 24 hours of life. ]
    Number of episodes of desaturation (SpO2 <80%) and bradycardia (<80 beats per minute)

  23. Clinical: Bronchopulmonary dysplasia (BPD) [ Time Frame: At 36 weeks postmenstrual age. ]
    BPD, maximum grade [number of cases]

  24. Clinical: Intraventricular haemorrhage (IVH) [ Time Frame: At 36 weeks postmenstrual age. ]
    IVH, maximum grade [number of cases]

  25. Clinical: Retinopathy of prematurity (ROP) [ Time Frame: At 36 weeks postmenstrual age. ]
    ROP, maximum grade [number of cases]

  26. Clinical: Necrotizing enterocolitis (NEC) [ Time Frame: At 36 weeks postmenstrual age. ]
    NEC, surgically treated [number of cases]

  27. Clinical: Blood-culture positive sepsis [ Time Frame: At 36 weeks postmenstrual age. ]
    Blood-culture positive sepsis [number of cases]


Other Outcome Measures:
  1. Safety: Death [ Time Frame: Until 36 weeks postmenstrual age. ]
    Death [number of cases]

  2. Safety: Pulmonary haemorrhage [ Time Frame: Until 36 weeks postmenstrual age. ]
    Pulmonary haemorrhage [number of cases]

  3. Safety: Air leak [ Time Frame: Until 36 weeks postmenstrual age. ]
    Air leak [number of cases]


Eligibility Criteria
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Ages Eligible for Study:   up to 3 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • severe congenital malformation adversely affecting surfactant nebulisation or life expectancy
  • a priori palliative care
  • genetically defined syndrome
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04315636


Locations
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Switzerland
Department of Neonatology, University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04315636    
Other Study ID Numbers: Surfactant nebulization
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Premature Birth
Syndrome
Disease
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents