Effect of surfactant dose on outcomes in preterm infants with respiratory distress syndrome: the OPTI-SURF study protocol
Related Experiment Video
Updated: Nov 26, 2025

Surfactant Depletion Combined with Injurious Ventilation Results in a Reproducible Model of the Acute Respiratory Distress Syndrome ARDS
Published on: April 7, 2021
Kevin Colin William Goss1, Chris Gale2, Rachel Malone3
1Neonatal Intensive Care Unit, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK kevingoss@nhs.net.
Insights
This study compares low versus high initial doses of surfactant for preterm infants with respiratory distress syndrome. The research aims to determine if lower doses improve survival without mechanical ventilation.
Area of Science:
- Neonatal Medicine
- Pediatric Respiratory Care
- Clinical Pharmacology
Background:
- Respiratory distress syndrome (RDS) is common in preterm infants due to surfactant deficiency.
- European guidelines exist for surfactant administration, but clinical practice varies.
- A 'whole vial' dosing approach is frequently used, deviating from recommended doses.
Purpose of the Study:
- To evaluate the impact of a low initial surfactant dose (100-130 mg/kg) versus a high initial dose (170-200 mg/kg) in preterm infants (≤36 weeks+6 days).
- To assess the effect on survival without mechanical ventilation on postnatal days 3 and 4.
- To investigate other relevant neonatal outcomes associated with different surfactant dosing strategies.
Main Methods:
- Prospective, observational study design.
- Utilizing the National Neonatal Research Database for primary data.
- Supplementing data with neonatal electronic patient record (EPR) system for surfactant administration details.
- Employing propensity score matching to create comparable groups for low and high dose comparisons.
Main Results:
- Pre-results phase; data collection and analysis are ongoing.
- The study will provide insights into the efficacy of different surfactant dosing regimens.
- Outcomes will be analyzed to determine clinical significance and potential practice changes.
Conclusions:
- Findings will inform clinical practice regarding optimal surfactant dosing for preterm infants with RDS.
- The study aims to contribute evidence-based recommendations to neonatal care guidelines.
- Results will be disseminated through publications and conference presentations.
Introduction:
Respiratory distress syndrome is a condition seen in preterm infants primarily due to surfactant insufficiency. European guidelines recommend the dose and method of surfactant administration. However, in routine practice, clinicians often use a 'whole vial' approach to surfactant dosing. The aim of this study is to assess whether in preterm infants of gestational age 36+6 weeks+days or less, a low first dose of surfactant (100-130 mg/kg) compared with a high first dose (170-200 mg/kg) affects survival with no mechanical ventilation on either on postnatal days 3 and 4, and other outcomes.
Methods And Analysis:
In this prospective, observational study, we will use the National Neonatal Research Database as the main data source. We will obtain additional information describing the dose and method of surfactant administration through the neonatal EPR system. We will use propensity scores to form matched groups with low first dose and high first dose for comparison.
Ethics And Dissemination:
This study was approved by the West Midlands-Black Country Research Ethics Committee (REC reference: 18/WM/0132; IRAS project ID: 237111). The results of the research will be made publicly available through presentations at local, national or international conferences and will be submitted for publication in a peer-reviewed journal.
Trial Registration Number:
NCT03808402; Pre-results.
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