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The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS (OPTI-SURF)

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Chiesi

Status

Active, not recruiting

Conditions

Respiratory Distress Syndrome
Bronchopulmonary Dysplasia

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03808402
36652 (Other Identifier)
IRAS 237111

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,973 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • <37 weeks gestational age Requiring surfactant for Respiratory Distress Syndrome Record of birth weight available Born after study initiation

Exclusion criteria

  • 37 weeks gestation age or above Parental opt-out

Trial design

2,973 participants in 2 patient groups

High dose surfactant
Description:
Infants who receive a first dose of surfactant between 170 and 200 mg/kg
Low dose surfactant
Description:
Infants who receive a first dose of surfactant between 100 and 130 mg/kg

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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