Clinical trial NCT03808402: The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
Official title: The Effect of Surfactant Dose on Outcomes in Preterm Infants With Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Keywords: Surfactant
Less Invasive Surfactant Administration
Mechanical Ventilation
Lead sponsor: Chiesi UK
Sponsor class: INDUSTRY
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
name: Imperial College London
First posted: 2019-01-17
Enrollment: 2973
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants born in neonatal units in the UK

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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for mechanical ventilation
timeFrame: Day 3 to 4 of life
Secondary outcomes:
measure: Survival
timeFrame: To study completion, an average of 2 years
measure: Number of doses of surfactant
timeFrame: To study completion, an average of 2 years
measure: Total cumulative dose of surfactant (excluding the first dose)
timeFrame: To study completion, an average of 2 years
measure: Survival with no respiratory support
timeFrame: On postnatal day 28
measure: Survival with no respiratory support
timeFrame: 36 weeks gestation
measure: Survival with no oxygen requirement
timeFrame: To study completion, an average of 2 years
measure: Duration of mechanical ventilation (days)
timeFrame: To study completion, an average of 2 years
measure: Duration of respiratory support (days)
timeFrame: To study completion, an average of 2 years
measure: Two-year developmental outcomes
timeFrame: Two years
measure: Two-year developmental outcomes
timeFrame: Two years
Other outcomes:
measure: Effect of dose on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2)
timeFrame: Day 3 to 4 of life
measure: Effect of method of administration on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2)
timeFrame: Day 3 to 4 of life
Locations:
city: Ashford
country: United Kingdom
facility: William Harvey Hospital
state: Kent
city: Birmingham
country: United Kingdom
facility: Birmingham Women's Hospital
city: Birmingham
country: United Kingdom
facility: Birmigham Heartlands Hospital
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Burnley
country: United Kingdom
facility: Burnley General Hospital
city: Cambridge
country: United Kingdom
facility: The Rosie Hospital
city: Chertsey
country: United Kingdom
facility: St Peter's Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Liverpool
country: United Kingdom
facility: Liverpool Women's Hospital
city: London
country: United Kingdom
facility: Homerton Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: Manchester
country: United Kingdom
facility: St Mary's Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Middlesbrough
country: United Kingdom
facility: The James Cook Hospital
city: Middlesbrough
country: United Kingdom
facility: University Hospital of North Tees
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Sheffield
country: United Kingdom
facility: Jessop Wing
city: Southampton
country: United Kingdom
facility: Princess Anne Hospital
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Kevin Goss, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goss KCW, Gale C, Malone R, Longford N, Ratcliffe K, Modi N. Effect of surfactant dose on outcomes in preterm infants with respiratory distress syndrome: the OPTI-SURF study protocol. BMJ Open. 2020 Dec 12;10(12):e038959. doi: 10.1136/bmjopen-2020-038959.