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| ID | Type | Description | Link |
|---|---|---|---|
| Studio Numero 6379 | Other Identifier | Comitato Etico Milano Area 2 |
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| Name | Class |
|---|---|
| Politecnico di Milano | OTHER |
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This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will allow a 5-day reduction in the duration of respiratory support as compared to standard practice in preterm infants between 27+0 and 32+6 weeks' gestation. The secondary objectives are:
Infants matching the clinical criteria for inclusion will be randomized in two arms following the current data protection and confidentiality regulations. Central, computer-generated randomization (allocation 1:1) with variable block sizes according to gestational age will be used. Infants will be stratified according to gestational age (27+0 -28+6 weeks; 29+0 -30+6 weeks; 31+0 -32+6 weeks) and center.
Study Arms:
A) Surfactant administration following oxygenation-based criteria (clinical assessment) (control) B) Surfactant administration following both lung mechanics assessment OR oxygenation-based criteria (clinical assessment) (intervention).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/Control | Active Comparator | Surfactant administration following clinical assessment |
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| B/Intervention | Experimental | Surfactant administration following both lung mechanics assessment and clinical assessment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surfactant administration following lung mechanics assessment in addition to clinical assessment | Other | Surfactant is administered following oxygenation-based criteria and if the Xrs is ≤ -23.3 cmH2O*s /L |
| Measure | Description | Time Frame |
|---|---|---|
| Days of respiratory support | Number of days of required respiratory support | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Measure | Description | Time Frame |
|---|---|---|
| First surfactant administration | Time of first surfactant administration (in hours) | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Days of non-invasive respiratory support |
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Inclusion Criteria:
Exclusion Criteria:
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Randomized controlled trial
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| Surfactant administration following clinical assessment | Other | Surfactant is administered following oxygenation-based criteria |
|
Number of days of non-invasive respiratory support |
| From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Days of invasive respiratory support | Number of days of invasive respiratory support | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Patients intubated and mechanically ventilated | Number of patients intubated and mechanically ventilated | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Patients receiving multiple surfactant doses | Number of patients receiving multiple surfactant doses | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Days on supplemental oxygen | Number of days on supplemental oxygen | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Total cumulative oxygen exposure | Total cumulative oxygen exposure computed as the time integral of the FiO2 values | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Infants receiving more than 28 days of respiratory support | Number of infants receiving more than 28 days of respiratory support | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Infants developing BPD | Number of infants developing BPD according to the definition by NICHD 2016 | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Infants developing air-leaks | Number of infants developing air-leaks | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Infants developing prematurity-associated complications | Number of infants developing prematurity-associated complications (severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), sepsis, retinopathy of prematurity (ROP), patent ductus arteriosus requiring pharmacological or surgical treatment) | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Infants discharged home with oxygen or respiratory support | Number of infants discharged home with oxygen or respiratory support | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Days to achieve full-enteral feeding | Number of days to achieve full-enteral feeding (160 ml/kg/day of milk intake) | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Days of hospitalization | Number of days of hospitalization | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| Infants receiving postnatal steroids | Number of infants receiving postnatal steroids | From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months" |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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