Bronchopulmonary Dysplasia, Respiratory Distress Syndrome
Conditions
Keywords
Surfactant, Less Invasive Surfactant Administration, Mechanical Ventilation
Brief 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.
Interventions
None listed
Sponsors
The Leeds Teaching Hospitals NHS Trust
Imperial College London
Chiesi UK
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for mechanical ventilation | Day 3 to 4 of life | Survival without mechanical ventilation (excluding days 1 and 2 of life) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Duration of respiratory support (days) | To study completion, an average of 2 years | — |
| Two-year developmental outcomes | Two years | As measured by Bailey's Score |
| 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 | — |
Other
| Measure | Time frame |
|---|---|
| Effect of dose on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2) | Day 3 to 4 of life |
| Effect of method of administration on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2) | Day 3 to 4 of life |
Countries
United Kingdom
Outcome results
None listed