Surfactant Nebulization for the Early Aeration of the Preterm Lung

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2022-01-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Preterm Birth Respiratory Distress Syndrome Surfactant Deficiency Syndrome Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Surfactant nebulisation

Intervention Type 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).

Standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

3 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No