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

Primary Purpose

Preterm Birth, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Surfactant nebulisation
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

undefined - 3 Minutes (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neonatology, University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surfactant nebulisation

Standard care

Arm Description

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.

The control group will receive standard care (PEEP, +/- noninvasive positive pressure ventilation, without surfactant nebulisation).

Outcomes

Primary Outcome Measures

EIT: End-expiratory lung impedance (EELI)
Change in EELI using electrical impedance tomography (arbitrary units per kilogram)

Secondary Outcome Measures

EIT: End-expiratory lung impedance (EELI)
EELI using electrical impedance tomography (arbitrary units per kilogram).
EIT: Regional ventilation distribution
Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram).
EIT: Tidal volumes
Tidal volumes using electrical impedance tomography (arbitrary units per kilogram).
EIT: Association between EELI losses and SpO2/FiO2 ratio.
Association between the number of EELI losses >50% and the SpO2/FiO2 ratio.
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.
Physiological: Heart rate
Continuous recording of heart rate (beats per minute).
Physiological: Oxygen saturation (SpO2)
Continuous recording of SpO2 (%).
Physiological: Fraction of inspired oxygen
Continuous recording of fraction of inspired oxygen.
Physiological: SpO2/FiO2 ratio
SpO2/FiO2 ratio.
Physiological: Body temperature
Number of events with body temperature <36.5 or >37.5°C.
Respiratory: Peak inspiratory pressure (PIP)
Continuous recording of PIP in the control group (cmH2O).
Respiratory: Positive end-expiratory pressure (PEEP)
Continuous recording of PEEP in the control group (cmH2O).
Respiratory: Tidal volume (Vt)
Continuous recording of Vt in the control group (cmH2O).
Respiratory: PEEP (positive end-expiratory pressure)
PEEP during noninvasive and invasive ventilation [mbar]
Respiratory: PIP (peak inspiratory pressure)
PIP during noninvasive and invasive ventilation [mbar]
Respiratory: Respiratory rate
Respiratory rate during noninvasive and invasive ventilation [breaths per minute]
Clinical: Length and type of noninvasive respiratory support
Total length of CPAP/NIPPV support assessed retrospectively using video recordings (min)
Clinical: Total time on noninvasive and invasive respiratory support
Total time on invasive and noninvasive respiratory support (days)
Clinical: Frequency and duration of facemask repositioning
Frequency and duration of facemask repositioning assessed retrospectively using video recordings.
Clinical: Intubation
Intubation rate (%)
Clinical: Time to first intubation
Time to first intubation (days, minutes)
Clinical: Number of episodes of desaturation and bradycardia
Number of episodes of desaturation (SpO2 <80%) and bradycardia (<80 beats per minute)
Clinical: Bronchopulmonary dysplasia (BPD)
BPD, maximum grade [number of cases]
Clinical: Intraventricular haemorrhage (IVH)
IVH, maximum grade [number of cases]
Clinical: Retinopathy of prematurity (ROP)
ROP, maximum grade [number of cases]
Clinical: Necrotizing enterocolitis (NEC)
NEC, surgically treated [number of cases]
Clinical: Blood-culture positive sepsis
Blood-culture positive sepsis [number of cases]

Full Information

First Posted
March 6, 2020
Last Updated
November 21, 2022
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04315636
Brief Title
Surfactant Nebulization for the Early Aeration of the Preterm Lung
Acronym
SUNSET
Official Title
Surfactant Nebulization for the Early Aeration of the Preterm Lung: a Single Blinded, Parallel, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
January 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surfactant nebulisation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
The control group will receive standard care (PEEP, +/- noninvasive positive pressure ventilation, without surfactant nebulisation).
Intervention Type
Drug
Intervention Name(s)
Surfactant nebulisation
Intervention Description
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).
Primary Outcome Measure Information:
Title
EIT: End-expiratory lung impedance (EELI)
Description
Change in EELI using electrical impedance tomography (arbitrary units per kilogram)
Time Frame
Between birth and 30 minutes of life.
Secondary Outcome Measure Information:
Title
EIT: End-expiratory lung impedance (EELI)
Description
EELI using electrical impedance tomography (arbitrary units per kilogram).
Time Frame
At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age
Title
EIT: Regional ventilation distribution
Description
Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram).
Time Frame
At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.
Title
EIT: Tidal volumes
Description
Tidal volumes using electrical impedance tomography (arbitrary units per kilogram).
Time Frame
At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.
Title
EIT: Association between EELI losses and SpO2/FiO2 ratio.
Description
Association between the number of EELI losses >50% and the SpO2/FiO2 ratio.
Time Frame
At 6, 12, and 24 hours of life.
Title
EIT: Association between EELI losses and need/level of respiratory support.
Description
Association between the number of EELI losses >50% and the need/level of respiratory support.
Time Frame
At 6, 12, and 24 hours of life.
Title
Physiological: Heart rate
Description
Continuous recording of heart rate (beats per minute).
Time Frame
For the first 30 minutes after birth, as well as at 6, 12, and 24 hours of life.
Title
Physiological: Oxygen saturation (SpO2)
Description
Continuous recording of SpO2 (%).
Time Frame
For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.
Title
Physiological: Fraction of inspired oxygen
Description
Continuous recording of fraction of inspired oxygen.
Time Frame
For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.
Title
Physiological: SpO2/FiO2 ratio
Description
SpO2/FiO2 ratio.
Time Frame
At 6, 12, and 24 hours of life.
Title
Physiological: Body temperature
Description
Number of events with body temperature <36.5 or >37.5°C.
Time Frame
In the delivery room.
Title
Respiratory: Peak inspiratory pressure (PIP)
Description
Continuous recording of PIP in the control group (cmH2O).
Time Frame
During the first 30 minutes of life.
Title
Respiratory: Positive end-expiratory pressure (PEEP)
Description
Continuous recording of PEEP in the control group (cmH2O).
Time Frame
During the first 30 minutes of life.
Title
Respiratory: Tidal volume (Vt)
Description
Continuous recording of Vt in the control group (cmH2O).
Time Frame
During the first 30 minutes of life.
Title
Respiratory: PEEP (positive end-expiratory pressure)
Description
PEEP during noninvasive and invasive ventilation [mbar]
Time Frame
At 6, 12, and 24 hours of life.
Title
Respiratory: PIP (peak inspiratory pressure)
Description
PIP during noninvasive and invasive ventilation [mbar]
Time Frame
At 6, 12, and 24 hours of life.
Title
Respiratory: Respiratory rate
Description
Respiratory rate during noninvasive and invasive ventilation [breaths per minute]
Time Frame
At 6, 12, and 24 hours of life.
Title
Clinical: Length and type of noninvasive respiratory support
Description
Total length of CPAP/NIPPV support assessed retrospectively using video recordings (min)
Time Frame
During the first 30 minutes of life.
Title
Clinical: Total time on noninvasive and invasive respiratory support
Description
Total time on invasive and noninvasive respiratory support (days)
Time Frame
Until 36 weeks postmenstrual age
Title
Clinical: Frequency and duration of facemask repositioning
Description
Frequency and duration of facemask repositioning assessed retrospectively using video recordings.
Time Frame
During the first 30 minutes after birth.
Title
Clinical: Intubation
Description
Intubation rate (%)
Time Frame
At 24 and 72 hours of life, at 7 days of life. Until 36 weeks postmenstrual age.
Title
Clinical: Time to first intubation
Description
Time to first intubation (days, minutes)
Time Frame
From birth until 36 weeks postmenstrual age.
Title
Clinical: Number of episodes of desaturation and bradycardia
Description
Number of episodes of desaturation (SpO2 <80%) and bradycardia (<80 beats per minute)
Time Frame
During the first 24 hours of life.
Title
Clinical: Bronchopulmonary dysplasia (BPD)
Description
BPD, maximum grade [number of cases]
Time Frame
At 36 weeks postmenstrual age.
Title
Clinical: Intraventricular haemorrhage (IVH)
Description
IVH, maximum grade [number of cases]
Time Frame
At 36 weeks postmenstrual age.
Title
Clinical: Retinopathy of prematurity (ROP)
Description
ROP, maximum grade [number of cases]
Time Frame
At 36 weeks postmenstrual age.
Title
Clinical: Necrotizing enterocolitis (NEC)
Description
NEC, surgically treated [number of cases]
Time Frame
At 36 weeks postmenstrual age.
Title
Clinical: Blood-culture positive sepsis
Description
Blood-culture positive sepsis [number of cases]
Time Frame
At 36 weeks postmenstrual age.
Other Pre-specified Outcome Measures:
Title
Safety: Death
Description
Death [number of cases]
Time Frame
Until 36 weeks postmenstrual age.
Title
Safety: Pulmonary haemorrhage
Description
Pulmonary haemorrhage [number of cases]
Time Frame
Until 36 weeks postmenstrual age.
Title
Safety: Air leak
Description
Air leak [number of cases]
Time Frame
Until 36 weeks postmenstrual age.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Minutes
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Neonatology, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30049729
Citation
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. Erratum In: Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):e1.
Results Reference
background
PubMed Identifier
35398844
Citation
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.
Results Reference
derived

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Surfactant Nebulization for the Early Aeration of the Preterm Lung

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