OPTI-SURF: Optimising surfactant use in neonatal RDS
Research type
Research Study
Full title
OPTI-SURF: Optimal surfactant delivery for preterm babies with respiratory distress syndrome. The effect of surfactant dose on outcomes in preterm infants with Respiratory Distress Syndrome
IRAS ID
237111
Contact name
Kevin Goss
Contact email
Sponsor organisation
Chiesi Limited
Clinicaltrials.gov Identifier
CPMS ID, CHIL 36652; R&I Leeds, PA18/107045
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Despite significant advances in the care of newborn premature babies in the last 30 years they remain at risk of significant complications secondary to the development of neonatal respiratory distress syndrome (nRDS).
The treatment for nRDS includes mechanical breathing support and early administration of surfactant replacement therapy. A range of surfactant doses can be used and may therefore vary between neonatal units (NNUs).
It is not clear what the optimum dose of surfactant replacement is and whether differences in the dosage received affects a baby’s clinical outcome.This database study, which involves no change in clinical practice, is designed to understand how babies in Great Britain, who are delivered prematurely and are at risk of developing nRDS, are cared for in the first hours and days of life and to determine whether the amount of surfactant medication that they receive affects their outcomes.
Most babies born prematurely in this country are admitted to a NNU. All NNUs in Great Britain use a summary electronic patient record system (computerised medical notes) to record clinical information on babies. This information is used to create a research database called the National Neonatal Research Database (NNRD). Data held in the NNRD are anonymised (so individual babies cannot be identified); parents can choose not to have their baby's data included in the NNRD. NNRD was created through the collaborative efforts of neonatal services across the country to be a national resource.
This study will use data that is entered as part of routine clinical care of babies that receive neonatal care, and held in the NNRD.
This study will collect de-identified data from participating NNUs. Parents of eligible babies will have the option to opt-out from inclusion. The study aims to recruit 1300 babies and will include data collected up to two years after delivery.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
18/WM/0132
Date of REC Opinion
1 May 2018
REC opinion
Favourable Opinion