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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
32
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).
Department of Neonatology, University Hospital Zurich
Zurich, Switzerland
EIT: End-expiratory lung impedance (EELI)
Change in EELI using electrical impedance tomography (arbitrary units per kilogram)
Time frame: Between birth and 30 minutes of life.
EIT: End-expiratory lung impedance (EELI)
EELI using electrical impedance tomography (arbitrary units per kilogram).
Time frame: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age
EIT: Regional ventilation distribution
Regional ventilation distribution using electrical impedance tomography (arbitrary units per kilogram).
Time frame: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.
EIT: Tidal volumes
Tidal volumes using electrical impedance tomography (arbitrary units per kilogram).
Time frame: At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.
EIT: Association between EELI losses and SpO2/FiO2 ratio.
Association between the number of EELI losses \>50% and the SpO2/FiO2 ratio.
Time frame: At 6, 12, and 24 hours of life.
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.
Time frame: At 6, 12, and 24 hours of life.
Physiological: Heart rate
Continuous recording of heart rate (beats per minute).
Time frame: For the first 30 minutes after birth, as well as at 6, 12, and 24 hours of life.
Physiological: Oxygen saturation (SpO2)
Continuous recording of SpO2 (%).
Time frame: For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.
Physiological: Fraction of inspired oxygen
Continuous recording of fraction of inspired oxygen.
Time frame: For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.
Physiological: SpO2/FiO2 ratio
SpO2/FiO2 ratio.
Time frame: At 6, 12, and 24 hours of life.
Physiological: Body temperature
Number of events with body temperature \<36.5 or \>37.5°C.
Time frame: In the delivery room.
Respiratory: Peak inspiratory pressure (PIP)
Continuous recording of PIP in the control group (cmH2O).
Time frame: During the first 30 minutes of life.
Respiratory: Positive end-expiratory pressure (PEEP)
Continuous recording of PEEP in the control group (cmH2O).
Time frame: During the first 30 minutes of life.
Respiratory: Tidal volume (Vt)
Continuous recording of Vt in the control group (cmH2O).
Time frame: During the first 30 minutes of life.
Respiratory: PEEP (positive end-expiratory pressure)
PEEP during noninvasive and invasive ventilation \[mbar\]
Time frame: At 6, 12, and 24 hours of life.
Respiratory: PIP (peak inspiratory pressure)
PIP during noninvasive and invasive ventilation \[mbar\]
Time frame: At 6, 12, and 24 hours of life.
Respiratory: Respiratory rate
Respiratory rate during noninvasive and invasive ventilation \[breaths per minute\]
Time frame: At 6, 12, and 24 hours of life.
Clinical: Length and type of noninvasive respiratory support
Total length of CPAP/NIPPV support assessed retrospectively using video recordings (min)
Time frame: During the first 30 minutes of life.
Clinical: Total time on noninvasive and invasive respiratory support
Total time on invasive and noninvasive respiratory support (days)
Time frame: Until 36 weeks postmenstrual age
Clinical: Frequency and duration of facemask repositioning
Frequency and duration of facemask repositioning assessed retrospectively using video recordings.
Time frame: During the first 30 minutes after birth.
Clinical: Intubation
Intubation rate (%)
Time frame: At 24 and 72 hours of life, at 7 days of life. Until 36 weeks postmenstrual age.
Clinical: Time to first intubation
Time to first intubation (days, minutes)
Time frame: From birth until 36 weeks postmenstrual age.
Clinical: Number of episodes of desaturation and bradycardia
Number of episodes of desaturation (SpO2 \<80%) and bradycardia (\<80 beats per minute)
Time frame: During the first 24 hours of life.
Clinical: Bronchopulmonary dysplasia (BPD)
BPD, maximum grade \[number of cases\]
Time frame: At 36 weeks postmenstrual age.
Clinical: Intraventricular haemorrhage (IVH)
IVH, maximum grade \[number of cases\]
Time frame: At 36 weeks postmenstrual age.
Clinical: Retinopathy of prematurity (ROP)
ROP, maximum grade \[number of cases\]
Time frame: At 36 weeks postmenstrual age.
Clinical: Necrotizing enterocolitis (NEC)
NEC, surgically treated \[number of cases\]
Time frame: At 36 weeks postmenstrual age.
Clinical: Blood-culture positive sepsis
Blood-culture positive sepsis \[number of cases\]
Time frame: At 36 weeks postmenstrual age.
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