Surfactant Nebulization for the Early Aeration of the Preterm Lung

Preterm Birth Clinical Trial

— SUNSET  

Official title:

Surfactant Nebulization for the Early Aeration of the Preterm Lung: a Single Blinded, Parallel, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315636
• Other study ID #: Surfactant nebulization
• Status: Completed
• Phase: Phase 3
• Start date: March 19, 2021
• Est. completion date: January 16, 2022

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 16, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Surfactant Deficiency Syndrome Neonatal
• Syndrome

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Switzerland	Department of Neonatology, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

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