Surfactant Nebulization for the Early Aeration of the Preterm Lung

Phase 3

Completed

• Conditions: Preterm Birth; Respiratory Distress Syndrome; Surfactant Deficiency Syndrome Neonatal
• Interventions: Drug: Surfactant nebulisation

• Registration Number: NCT04315636
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2021-03-19
• Primary Completion: 2021-11-01
• Study Completion: 2022-01-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surfactant nebulisation	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.

Primary Outcome Measures

Name	Time	Method
EIT: End-expiratory lung impedance (EELI)	Between birth and 30 minutes of life.	Change in EELI using electrical impedance tomography (arbitrary units per kilogram)

Secondary Outcome Measures

Name	Time	Method
Clinical: Intraventricular haemorrhage (IVH)	At 36 weeks postmenstrual age.	IVH, maximum grade \[number of cases\]
Clinical: Retinopathy of prematurity (ROP)	At 36 weeks postmenstrual age.	ROP, maximum grade \[number of cases\]
Clinical: Necrotizing enterocolitis (NEC)	At 36 weeks postmenstrual age.	NEC, surgically treated \[number of cases\]
EIT: End-expiratory lung impedance (EELI)	At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age	EELI using electrical impedance tomography (arbitrary units per kilogram).
Clinical: Number of episodes of desaturation and bradycardia	During the first 24 hours of life.	Number of episodes of desaturation (SpO2 \<80%) and bradycardia (\<80 beats per minute)
Clinical: Bronchopulmonary dysplasia (BPD)	At 36 weeks postmenstrual age.	BPD, maximum grade \[number of cases\]
EIT: Regional ventilation distribution	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).
EIT: Tidal volumes	At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.	Tidal volumes using electrical impedance tomography (arbitrary units per kilogram).
EIT: Association between EELI losses and SpO2/FiO2 ratio.	At 6, 12, and 24 hours of life.	Association between the number of EELI losses \>50% and the SpO2/FiO2 ratio.
EIT: Association between EELI losses and need/level of respiratory support.	At 6, 12, and 24 hours of life.	Association between the number of EELI losses \>50% and the need/level of respiratory support.
Physiological: Oxygen saturation (SpO2)	For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.	Continuous recording of SpO2 (%).
Physiological: Fraction of inspired oxygen	For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.	Continuous recording of fraction of inspired oxygen.
Respiratory: PIP (peak inspiratory pressure)	At 6, 12, and 24 hours of life.	PIP during noninvasive and invasive ventilation \[mbar\]
Respiratory: Respiratory rate	At 6, 12, and 24 hours of life.	Respiratory rate during noninvasive and invasive ventilation \[breaths per minute\]
Clinical: Length and type of noninvasive respiratory support	During the first 30 minutes of life.	Total length of CPAP/NIPPV support assessed retrospectively using video recordings (min)
Clinical: Total time on noninvasive and invasive respiratory support	Until 36 weeks postmenstrual age	Total time on invasive and noninvasive respiratory support (days)
Clinical: Frequency and duration of facemask repositioning	During the first 30 minutes after birth.	Frequency and duration of facemask repositioning assessed retrospectively using video recordings.
Clinical: Intubation	At 24 and 72 hours of life, at 7 days of life. Until 36 weeks postmenstrual age.	Intubation rate (%)
Clinical: Time to first intubation	From birth until 36 weeks postmenstrual age.	Time to first intubation (days, minutes)
Clinical: Blood-culture positive sepsis	At 36 weeks postmenstrual age.	Blood-culture positive sepsis \[number of cases\]
Physiological: Heart rate	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).
Physiological: SpO2/FiO2 ratio	At 6, 12, and 24 hours of life.	SpO2/FiO2 ratio.
Respiratory: Positive end-expiratory pressure (PEEP)	During the first 30 minutes of life.	Continuous recording of PEEP in the control group (cmH2O).
Respiratory: Tidal volume (Vt)	During the first 30 minutes of life.	Continuous recording of Vt in the control group (cmH2O).
Respiratory: PEEP (positive end-expiratory pressure)	At 6, 12, and 24 hours of life.	PEEP during noninvasive and invasive ventilation \[mbar\]
Physiological: Body temperature	In the delivery room.	Number of events with body temperature \<36.5 or \>37.5°C.
Respiratory: Peak inspiratory pressure (PIP)	During the first 30 minutes of life.	Continuous recording of PIP in the control group (cmH2O).

Trial Locations

Locations (1)

Department of Neonatology, University Hospital Zurich; 🇨🇭 Zurich, Switzerland