Preterm Infants at risk of respiratory distress syndrome MedDRA version: 20.0 Level: PT Classification code 10054933 Term: Neonatal respiratory distress syndrome prophylaxis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: CUROSURF®
Product Name: CUROSURF®
Pharmaceutical Form: Endotracheopulmonary instillation, suspension
INN or Proposed INN: Poractant Alfa
CAS Number: 129069-19-8
Other descriptive name: POR
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • born at a participating centres with a gestational age at birth =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Infants with major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA/ASD/VSD), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g. T21, T13, T18 - The treating clinician does not intend to offer the infant intensive care. - Written informed consent has not been obtained prior to delivery or subjects’ parent(s)/guardian(s) withdraws consent following enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our primary objective is to investigate the efficacy of prophylactic oropharyngeal surfactant for reducing the rate of endotracheal intubation, compared to no intervention in infants at risk of RDS.;Secondary Objective: To investigate the efficacy of prophylactic oropharyngeal surfactant compared to no intervention for preventing some possible complications in premature infants at risk of RDS, we will also record a number of variables relating to prematurity, from enrolment into the trial until discharge home from hospital.;Primary end point(s): The incidence of endotracheal intubation for respiratory failure within 120 hours of birth. Enrolled infants will be intubated for persistent apnoea and/or bradycardia in the DR, or for respiratory failure in the NICU defined as = 2 of: • Clinical signs – worsening tachypnoea; grunting; subcostal, intercostal and/or sternal recession • Acidosis – pH 0.4 to keep SpO2 = 90% for > 30 minutes • PCO2 > 9.0 kPa on 2 blood gases (arterial or capillary) = 30 minutes apart • Apnoea – recurrent apnoea treated with mask ventilation ;Timepoint(s) of evaluation of this end point: 120 hours after birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of attempts taken to successfully intubate in the DR 2. Chest compressions in the DR 3. Adrenaline administration in the DR 4. Rectal temperature on admission to the NICU 5. NICU intubation 6. Surfactant use before death or hospital discharge 7. Number of doses, including total dose 8. Intra-tracheal surfactant received post-intervention 9. Doses of post-intervention surfactant 10. Respiratory distress syndrome o Clinical evidence of respiratory distress with radiological evidence (ground glass appearance on CXR) 11. Incidence of pneumothorax o Incidence of pneumothorax on CXR 12. Incidence of pulmonary haemorrhage o Clinical evidence of pulmonary haemorrhage 13. Mechanical ventilation 14. Days of mechanical ventilation 15. Use of postnatal corticosteroids for ventilator dependence 16. Days of duration of respiratory support (endotracheal ventilation, high-frequency oscillatory ventilation, CPAP, heated humidified high-flow nasal cannula O2 ,low flow nasal cannula O2) 17. Bronchopulmonary dysplasia (BPD) –supplemental O2 at 28 days of life 18. Chronic lung disease of prematurity (CLD) – need for supplemental O2 at 36 weeks corrected gestational age (CGA) determined by physiological oxygen reduction test 19. Medical treatment for a patent ductus arteriosus o Administration of ibuprofen or paracetemol for PDA 20 Surgical treatment for a patent ductus arteriosus 21. Proven necrotising enterocolitis (= Bell’s stage 2) 22. Incidence of Intraventricular haemorrhage (IVH) (any and severe: IVH grade = 3) o Evidence on surveillance cranial ultrasounds performed regularly in NICU as standard of care 23. Incidence of cystic periventricular leukomalacia o Evidence on surveillance cranial ultrasounds performed regularly in NICU as standard of care 24. Retinopathy of prematurity treated with laser photocoagulation or intravitreal injections o Evidence on surveillance ophthalmology review performed regularly in NICU | — |
Countries
Belgium, Czech Republic, Denmark, Ireland, Italy, Norway, Portugal, Sweden
Contacts
Public ContactClinical Researcher
Luxembourg Institute of Health/Clinical and Epidemiological Investigation Center
Outcome results
None listed