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| ID | Type | Description | Link |
|---|---|---|---|
| 36652 | Other Identifier | CPMS |
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| Name | Class |
|---|---|
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| Imperial College London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose surfactant | Infants who receive a first dose of surfactant between 170 and 200 mg/kg | ||
| Low dose surfactant | Infants who receive a first dose of surfactant between 100 and 130 mg/kg |
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| 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 |
| 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) |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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Newborn infants born in neonatal units in the UK
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Goss, MBBS | Leeds Teaching Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Harvey Hospital | Ashford | Kent | TN24 0LZ | United Kingdom | ||
| Birmingham Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33310795 | Derived | 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. |
| Label | URL |
|---|---|
| Study website | View source |
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No plan to share IPD
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| 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 |
| Birmingham |
| B15 2TG |
| United Kingdom |
| Birmigham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| Royal Bolton Hospital | Bolton | BL4 0JR | United Kingdom |
| Bradford Royal Infirmary | Bradford | United Kingdom |
| Burnley General Hospital | Burnley | BB10 | United Kingdom |
| The Rosie Hospital | Cambridge | CB2 0SW | United Kingdom |
| St Peter's Hospital | Chertsey | KT16 0PZ | United Kingdom |
| University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| Leeds General Infirmary | Leeds | LS1 3EX | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Liverpool Women's Hospital | Liverpool | L8 7SS | United Kingdom |
| Homerton Hospital | London | E9 6SR | United Kingdom |
| University College Hospital | London | NW1 2BU' | United Kingdom |
| Guy's and St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
| St Mary's Hospital | Manchester | M13 9WL | United Kingdom |
| Wythenshawe Hospital | Manchester | M13 | United Kingdom |
| The James Cook Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| University Hospital of North Tees | Middlesbrough | United Kingdom |
| Royal Victoria Infirmary | Newcastle | Ne1 4LP | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | NR4 7UY | United Kingdom |
| Queens Medical Centre | Nottingham | NG7 2UH | United Kingdom |
| Royal Oldham Hospital | Oldham | OL1 2JH | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Queen Alexandra Hospital | Portsmouth | PO6 3LY | United Kingdom |
| Jessop Wing | Sheffield | S10 2SF | United Kingdom |
| Princess Anne Hospital | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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