Clinical trial NCT04315636: Surfactant Nebulization for the Early Aeration of the Preterm Lung
Official title: Surfactant Nebulization for the Early Aeration of the Preterm Lung: a Single Blinded, Parallel, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Birth
Respiratory Distress Syndrome
Surfactant Deficiency Syndrome Neonatal
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 32
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: EIT: End-expiratory lung impedance (EELI)
timeFrame: Between birth and 30 minutes of life.
Secondary outcomes:
measure: EIT: End-expiratory lung impedance (EELI)
timeFrame: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age
measure: EIT: Regional ventilation distribution
timeFrame: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.
measure: EIT: Tidal volumes
timeFrame: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.
measure: EIT: Association between EELI losses and SpO2/FiO2 ratio.
timeFrame: At 6, 12, and 24 hours of life.
measure: EIT: Association between EELI losses and need/level of respiratory support.
timeFrame: At 6, 12, and 24 hours of life.
measure: Physiological: Heart rate
timeFrame: For the first 30 minutes after birth, as well as at 6, 12, and 24 hours of life.
measure: Physiological: Oxygen saturation (SpO2)
timeFrame: For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.
measure: Physiological: Fraction of inspired oxygen
timeFrame: For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.
measure: Physiological: SpO2/FiO2 ratio
timeFrame: At 6, 12, and 24 hours of life.
measure: Physiological: Body temperature
timeFrame: In the delivery room.
measure: Respiratory: Peak inspiratory pressure (PIP)
timeFrame: During the first 30 minutes of life.
measure: Respiratory: Positive end-expiratory pressure (PEEP)
timeFrame: During the first 30 minutes of life.
measure: Respiratory: Tidal volume (Vt)
timeFrame: During the first 30 minutes of life.
measure: Respiratory: PEEP (positive end-expiratory pressure)
timeFrame: At 6, 12, and 24 hours of life.
measure: Respiratory: PIP (peak inspiratory pressure)
timeFrame: At 6, 12, and 24 hours of life.
measure: Respiratory: Respiratory rate
timeFrame: At 6, 12, and 24 hours of life.
measure: Clinical: Length and type of noninvasive respiratory support
timeFrame: During the first 30 minutes of life.
measure: Clinical: Total time on noninvasive and invasive respiratory support
timeFrame: Until 36 weeks postmenstrual age
measure: Clinical: Frequency and duration of facemask repositioning
timeFrame: During the first 30 minutes after birth.
measure: Clinical: Intubation
timeFrame: At 24 and 72 hours of life, at 7 days of life. Until 36 weeks postmenstrual age.
measure: Clinical: Time to first intubation
timeFrame: From birth until 36 weeks postmenstrual age.
measure: Clinical: Number of episodes of desaturation and bradycardia
timeFrame: During the first 24 hours of life.
measure: Clinical: Bronchopulmonary dysplasia (BPD)
timeFrame: At 36 weeks postmenstrual age.
measure: Clinical: Intraventricular haemorrhage (IVH)
timeFrame: At 36 weeks postmenstrual age.
measure: Clinical: Retinopathy of prematurity (ROP)
timeFrame: At 36 weeks postmenstrual age.
measure: Clinical: Necrotizing enterocolitis (NEC)
timeFrame: At 36 weeks postmenstrual age.
measure: Clinical: Blood-culture positive sepsis
timeFrame: At 36 weeks postmenstrual age.
Other outcomes:
measure: Safety: Death
timeFrame: Until 36 weeks postmenstrual age.
measure: Safety: Pulmonary haemorrhage
timeFrame: Until 36 weeks postmenstrual age.
measure: Safety: Air leak
timeFrame: Until 36 weeks postmenstrual age.
Locations:
city: Zurich
country: Switzerland
facility: Department of Neonatology, University Hospital Zurich
Study officials:
References:
citation: 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.
citation: 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.