Surfactant Nebulization for the Early Aeration of the Preterm Lung

NCT04315636 | Completed Phase 3

• 1 other identifier: Sunset
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Respiratory Distress Syndrome; Surfactant Deficiency Syndrome Neonatal

Outcome Measures

Primary Outcomes (1)

• EIT: End-expiratory lung impedance (EELI)

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

  Between birth and 30 minutes of life.

Secondary Outcomes (27)

• EIT: End-expiratory lung impedance (EELI)

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

• EIT: Regional ventilation distribution

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

• EIT: Tidal volumes

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

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

  At 6, 12, and 24 hours of life.

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

  At 6, 12, and 24 hours of life.

Other Outcomes (3)

• Safety: Death

  Until 36 weeks postmenstrual age.

• Safety: Pulmonary haemorrhage

  Until 36 weeks postmenstrual age.

• Safety: Air leak

  Until 36 weeks postmenstrual age.

Study Arms (2)

Surfactant nebulisation

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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

Interventions

Surfactant nebulisation DRUG

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).

Surfactant nebulisation

Eligibility Criteria

• Age: Up to 3 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Neonatology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 30049729 BACKGROUND

• 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.

  PMID: 38032260 DERIVED

• 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.

  PMID: 36424125 DERIVED

• 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.

  PMID: 35398844 DERIVED

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 19, 2020
• Study Start: March 19, 2021
• Primary Completion: November 1, 2021
• Study Completion: January 16, 2022
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)