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

University of Zurich (UZH)

Status and phase: Completed; Phase 3

Conditions: Respiratory Distress Syndrome; Surfactant Deficiency Syndrome Neonatal; Preterm Birth

Treatments: Drug: Surfactant nebulisation

Study type: Interventional

Funder types: Other

Identifiers

NCT04315636

Sunset

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: Under 3 minutes old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Surfactant nebulisation

Experimental group

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.

Treatment:

Drug: Surfactant nebulisation

Standard care

No Intervention group

Description:

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