REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
- Conditions
- Respiratory Distress Syndrome in Premature Infant
- Registration Number
- NCT05791331
- Brief Summary
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:
1. to determine if a lung mechanics-based approach for administering surfactant will change treatment timing; and
2. to assess the impact of the novel approach on other neonatal general outcomes. The study will take place within the neonatal intensive care units. Non-invasive respiratory support will be delivered by nasal CPAP with a starting pressure of 5-8 cmH2O. FiO2 will be titrated in order to achieve the target SpO2 91-95%.
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 458
- Gestational age (GA) ≥ 27+0 and < 33+0 weeks
- Spontaneously breathing infants, requiring non-invasive respiratory support (nasal CPAP or bilevel nasal CPAP). Criteria for commencement of non-invasive respiratory support: FiO2 >0.30 for target SpO2 88-93% or Silverman score ≥ 5.
- Inborn
- Written parental consent obtained
- Administration of Caffeine bolus 20 mg/kg IV or PO as per standard care
- Major congenital anomalies
- Need of intubation in delivery suite according to the AAP guidelines for neonatal resuscitation or early at the admission in NICU (within one hour from birth).
- Surfactant therapy prior to the study entry
- Severe birth asphyxia, defined by APGAR score ≤ 5 at 10 minutes after birth OR continued need for resuscitation 10 minutes after birth OR pH < 7.0 or base excess (BE) < -12 mmol/l on umbilical cord or on an arterial or capillary blood sample obtained within 1 hour from birth OR moderate to severe encephalopathy
- Respiratory failure secondary to conditions other that RDS as identified by lung imaging (air leaks, lung malformations...)
- Any clinical condition which may place the infants at undue risk as deemed by clinicians
- Participation to trials with competitive outcomes or likely to have an impact on the primary outcome of the study
- Outborn patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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" Number of days of required respiratory support
- Secondary Outcome Measures
Name Time Method Days to achieve full-enteral feeding 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" Number of days to achieve full-enteral feeding (160 ml/kg/day of milk intake)
First surfactant administration 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" Time of first surfactant administration (in hours)
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" Number of days of invasive respiratory support
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" Number of patients intubated and mechanically ventilated
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" Number of patients receiving multiple surfactant doses
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" Number of days on supplemental oxygen
Total cumulative oxygen exposure 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 computed as the time integral of the FiO2 values
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" Number of infants developing air-leaks
Infants developing prematurity-associated complications 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" 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)
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" Number of days of hospitalization
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" Number of days of non-invasive respiratory support
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" Number of infants receiving more than 28 days of respiratory support
Infants developing BPD 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" Number of infants developing BPD according to the definition by NICHD 2016
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" Number of infants discharged home with oxygen or respiratory support
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" Number of infants receiving postnatal steroids