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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Distress Syndrome, Bronchopulmonary Dysplasia

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High dose surfactant<br>Infants who receive a first dose of surfactant between 170 and 200 mg/kg | |
| Low dose surfactant<br>Infants who receive a first dose of surfactant between 100 and 130 mg/kg | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for mechanical ventilation | Survival without mechanical ventilation (excluding days 1 and 2 of life) | Day 3 to 4 of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | To study completion, an average of 2 years | 
| Number of doses of surfactant |  | To study completion, an average of 2 years | 
| Total cumulative dose of surfactant (excluding the first dose) |  | To study completion, an average of 2 years | 
| Survival with no respiratory support |  | On postnatal day 28 | 
| Survival with no respiratory support |  | 36 weeks gestation | 
| Survival with no oxygen requirement |  | To study completion, an average of 2 years | 
| Duration of mechanical ventilation (days) |  | To study completion, an average of 2 years | 
| Duration of respiratory support (days) |  | To study completion, an average of 2 years | 
| Two-year developmental outcomes | As measured by Bailey's Score | Two years | 
| Two-year developmental outcomes | As measured by Composite Developmental Assessment | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surfactant, Less Invasive Surfactant Administration, Mechanical Ventilation