Multicentre, open-label, randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory distress
Respiratory and cardiovascular disorders specific to the perinatal period
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 management. Infants allocated to the early surfactant therapy will receive a single dose of surfactant. For those infants allocated to the other arm, doctors will wait to see how their breathing responds to standard care. Infants in either arms may receive an additional dose of surfactant later on, if the doctor feels it is necessary. The researchers will collect some information such as duration of stay in hospital, duration of non-invasive support, breast milk feeding etc about the mother and infant their from medical records. The mother will be asked to fill in a short questionnaire after they provide consent and just before their infant leaves the hospital. The researchers will also keep a record of any hospital visits the infant has in their first year through routine NHS data.
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
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