NCT03808402

The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS

The Effect of Surfactant Dose on Outcomes in Preterm Infants With Respiratory Distress Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,973 (actual)
• Sponsor: Chiesi UK · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A prospective observational study using de-identified data from the Neonatal Network Research Database (NNRD) supplemented by additional information on dose, method of surfactant administration and dosing frequency to assess whether the dose and method of administration of surfactant given to preterm infants with respiratory distress syndrome (RDS) affects neonatal outcomes.

Detailed description

The rationale for this study is the clinical relevance of understanding whether surfactant dose affects neonatal outcomes in infants with RDS who are treated in the immediate postnatal period. In a research environment, the dose of surfactant is rigorously controlled, usually administered at a dose of 100mg/kg or 200mg/kg. In clinical practice, clinicians more frequently follow the 'whole vial dosing' approach, where a full vial is given aiming to get as close as possible to the desired dose. Reasons for whole vial use include reduction of waste and administration of surfactant shortly after birth where an infant's weight is unknown. It is unclear whether whole vial dosing leads to under-dosing or over-dosing and whether either situation affects outcomes. Information regarding the dose of surfactant delivered, and the method of administration, are not currently routinely recorded in the UK. The primary objective of the study is to compare two dosing groups (100-130 mg/kg and 170-200 mg/kg) in terms of the proportions of infants who require mechanical ventilation within four days of birth.

Conditions

• Respiratory Distress Syndrome
• Bronchopulmonary Dysplasia

Timeline

• Start date: 2018-10-26
• Primary completion: 2024-03-30
• Completion: 2024-03-30
• First posted: 2019-01-17
• Last updated: 2025-05-31

Locations

29 sites across 1 country: United Kingdom