Respiratory and cardiovascular disorders specific to the perinatal period Neonatal Diseases
Conditions
Interventions
This is a randomised controlled trial. Infants born 2-6 weeks early needing non-invasive respiratory support will be randomly allocated to receive either early surfactant therapy or expectant manageme
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
0 Days to 1 Days
Inclusion criteria
Inclusion criteria: 1. Born at 34+0–38+6 weeks of gestation 2. = 24 hours old 3. Respiratory distress defined as: 3.1. FiO2 = 0.3 and < 0.45 needed to maintain SaO2 =92%, or 3.2. Clinically significant work of breathing, regardless of FiO2 4. Clinical decision to provide non-invasive respiratory support 5. Written parental informed consent
Exclusion criteria
Exclusion criteria: 1. Major structural or chromosomal abnormality 2. No realistic prospect of survival 3. Prior intubation and/or surfactant administration 4. Known or suspected hypoxic ischaemic encephalopathy 5. Congenital abnormality of the upper or lower respiratory tract 6. Known or suspected neuromuscular disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Length of infant’s hospital stay after birth, defined as the number of days from birth to discharge home from hospital 2. Incidence of severe respiratory failure, defined as, sustained (= 30 minutes) requirement for FiO2 = 0.45 to maintain oxygen saturations (SaO2) = 92%, between trial entry and discharge home from hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Perinatal clinical outcomes measures: 1. Total duration of NNU stay, defined as total number of days of inpatient care in a neonatal unit (defined according to Healthcare Resource Group (HRG) Critical Care categories 1–5, 2016) 2. Total duration of neonatal intensive care, defined as number of days of neonatal intensive care (defined according to HRG Critical Care categories 1–5, 2016) 3. Duration of mechanical ventilation, defined as days of ventilation via an ETT 4. Duration of non-invasive respiratory support, using positive airway pressure or high flow 5. Pulmonary air leaks, requiring insertion of a chest drain 6. Days of mother-infant separation, defined using HRG Critical Care categories 1–5, 2016 7. Breast milk feeding, defined as (a) any breast milk feeding during neonatal hospital stay, (b) any breast milk feeding at hospital discharge and (c) exclusive breast milk feeding at hospital discharge 8. Late onset sepsis, defined as the incidence of microbiologically-confirmed or clinically suspected invasive infection more than 72 hours after birth 9. Need for inhaled nitric oxide (iNO) therapy 10. Need for Extra-corporeal membrane oxygenation (ECMO) 11. Medical respiratory diagnoses, defined as any respiratory diagnosis attributed to the infant 12. Surfactant administration, defined as (a) administration of any additional surfactant in infants randomised to receive early surfactant or (b) administration of any surfactant in infants receiving expectant management, including number of doses and dose given 13. Maternal length of hospitalisation, defined as the total number of days spent by the mother in hospital after trial entry Health economics outcomes measures: 14. Cost of maternal hospitalisation 15. Self-reported maternal health-related quality of life 16. Costs associated with neonatal care 17. Paediatric secondary care use and associated costs using routine national databases such as Hospital Episode Statistics (HES) data | — |
Countries
England, United Kingdom
Outcome results
None listed