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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surfactant nebulisation | Experimental | 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. |
|
| Standard care | No Intervention | The control group will receive standard care (PEEP, +/- noninvasive positive pressure ventilation, without surfactant nebulisation). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surfactant nebulisation | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| EIT: End-expiratory lung impedance (EELI) | Change in EELI using electrical impedance tomography (arbitrary units per kilogram) | Between birth and 30 minutes of life. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| EIT: Regional ventilation distribution |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Death | Death [number of cases] | Until 36 weeks postmenstrual age. |
| Safety: Pulmonary haemorrhage | Pulmonary haemorrhage [number of cases] |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neonatology, University Hospital Zurich | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30049729 | Background | 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. | |
| 38032260 | Derived |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Physiological: Oxygen saturation (SpO2) | Continuous recording of SpO2 (%). | 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. | For the first 30 minutes after birth, and at 6, 12, and 24 hours of life. |
| Physiological: SpO2/FiO2 ratio | SpO2/FiO2 ratio. | At 6, 12, and 24 hours of life. |
| Physiological: Body temperature | Number of events with body temperature <36.5 or >37.5°C. | In the delivery room. |
| Respiratory: Peak inspiratory pressure (PIP) | Continuous recording of PIP in the control group (cmH2O). | During the first 30 minutes of life. |
| Respiratory: Positive end-expiratory pressure (PEEP) | Continuous recording of PEEP in the control group (cmH2O). | During the first 30 minutes of life. |
| Respiratory: Tidal volume (Vt) | Continuous recording of Vt in the control group (cmH2O). | During the first 30 minutes of life. |
| Respiratory: PEEP (positive end-expiratory pressure) | PEEP during noninvasive and invasive ventilation [mbar] | At 6, 12, and 24 hours of life. |
| Respiratory: PIP (peak inspiratory pressure) | PIP during noninvasive and invasive ventilation [mbar] | At 6, 12, and 24 hours of life. |
| Respiratory: Respiratory rate | Respiratory rate during noninvasive and invasive ventilation [breaths per minute] | 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) | 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) | Until 36 weeks postmenstrual age |
| 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. |
| Clinical: Intubation | Intubation rate (%) | 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) | 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) | During the first 24 hours of life. |
| Clinical: Bronchopulmonary dysplasia (BPD) | BPD, maximum grade [number of cases] | At 36 weeks postmenstrual age. |
| Clinical: Intraventricular haemorrhage (IVH) | IVH, maximum grade [number of cases] | At 36 weeks postmenstrual age. |
| Clinical: Retinopathy of prematurity (ROP) | ROP, maximum grade [number of cases] | At 36 weeks postmenstrual age. |
| Clinical: Necrotizing enterocolitis (NEC) | NEC, surgically treated [number of cases] | At 36 weeks postmenstrual age. |
| Clinical: Blood-culture positive sepsis | Blood-culture positive sepsis [number of cases] | At 36 weeks postmenstrual age. |
| Until 36 weeks postmenstrual age. |
| Safety: Air leak | Air leak [number of cases] | Until 36 weeks postmenstrual age. |
| Gaertner VD, Buchler VL, Waldmann A, Bassler D, Ruegger CM. Deciphering Mechanisms of Respiratory Fetal-to-Neonatal Transition in Very Preterm Infants. Am J Respir Crit Care Med. 2024 Mar 15;209(6):738-747. doi: 10.1164/rccm.202306-1021OC. |
| 36424125 | Derived | Gaertner VD, Minocchieri S, Waldmann AD, Muhlbacher T, Bassler D, Ruegger CM; SUNSET study group. Prophylactic surfactant nebulisation for the early aeration of the preterm lung: a randomised clinical trial. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):217-223. doi: 10.1136/archdischild-2022-324519. Epub 2022 Nov 24. |
| 35398844 | Derived | 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. |
| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |