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

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ClinicalTrials.gov Identifier: NCT03808402
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Leeds Teaching Hospitals NHS Trust
Imperial College London
Information provided by (Responsible Party):
Chiesi 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.

Condition or disease
Respiratory Distress Syndrome Bronchopulmonary Dysplasia

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.


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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Surfactant Dose on Outcomes in Preterm Infants With Respiratory Distress Syndrome
Actual Study Start Date : October 26, 2018
Estimated Primary Completion Date : October 26, 2019
Estimated Study Completion Date : October 26, 2019


Group/Cohort
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



Primary Outcome Measures :
  1. Need for mechanical ventilation [ Time Frame: Day 3 to 4 of life ]
    Survival without mechanical ventilation (excluding days 1 and 2 of life)


Secondary Outcome Measures :
  1. Survival [ Time Frame: To study completion, an average of 2 years ]
  2. Number of doses of surfactant [ Time Frame: To study completion, an average of 2 years ]
  3. Total cumulative dose of surfactant (excluding the first dose) [ Time Frame: To study completion, an average of 2 years ]
  4. Survival with no respiratory support [ Time Frame: On postnatal day 28 ]
  5. Survival with no respiratory support [ Time Frame: 36 weeks gestation ]
  6. Survival with no oxygen requirement [ Time Frame: To study completion, an average of 2 years ]
  7. Duration of mechanical ventilation (days) [ Time Frame: To study completion, an average of 2 years ]
  8. Duration of respiratory support (days) [ Time Frame: To study completion, an average of 2 years ]
  9. Two-year developmental outcomes [ Time Frame: Two years ]
    As measured by Bailey's Score

  10. Two-year developmental outcomes [ Time Frame: Two years ]
    As measured by Composite Developmental Assessment


Other Outcome Measures:
  1. Effect of dose on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2) [ Time Frame: Day 3 to 4 of life ]
  2. Effect of method of administration on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2) [ Time Frame: Day 3 to 4 of life ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newborn infants born in neonatal units in the UK
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808402


Contacts
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Contact: Jonathan H Loukes, MBBS 00441614885555 j.loukes@chiesi.com
Contact: Rachel Malone, PhD 00441614885555 ext 00441614885555 r.malone@chiesi.com

Locations
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United Kingdom
William Harvey Hospital Recruiting
Ashford, Kent, United Kingdom, TN24 0LZ
Birmingham Women's Hospital Recruiting
Birmingham, United Kingdom, B15 2TG
Birmigham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Royal Bolton Hospital Recruiting
Bolton, United Kingdom, BL4 0JR
Bradford Royal Infirmary Recruiting
Bradford, United Kingdom
Burnley General Hospital Recruiting
Burnley, United Kingdom, BB10
The Rosie Hospital Recruiting
Cambridge, United Kingdom, CB2 0SW
St Peter's Hospital Not yet recruiting
Chertsey, United Kingdom, KT16 0PZ
University Hospital Coventry Recruiting
Coventry, United Kingdom, CV2 2DX
Hull Royal Infirmary Recruiting
Hull, United Kingdom, HU3 2JZ
Leeds General Infirmary Recruiting
Leeds, United Kingdom, LS1 3EX
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Liverpool Women's Hospital Recruiting
Liverpool, United Kingdom, L8 7SS
Homerton Hospital Recruiting
London, United Kingdom, E9 6SR
University College Hospital Recruiting
London, United Kingdom, NW1 2BU`
Guy's and St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Chelsea and Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
St Mary's Hospital Recruiting
Manchester, United Kingdom, M13 9WL
Wythenshawe Hospital Recruiting
Manchester, United Kingdom, M13
The James Cook Hospital Recruiting
Middlesbrough, United Kingdom, TS4 3BW
University Hospital of North Tees Recruiting
Middlesbrough, United Kingdom
Royal Victoria Infirmary Not yet recruiting
Newcastle, United Kingdom, Ne1 4LP
Norfolk and Norwich University Hospital Recruiting
Norwich, United Kingdom, NR4 7UY
Queens Medical Centre Recruiting
Nottingham, United Kingdom, NG7 2UH
Royal Oldham Hospital Recruiting
Oldham, United Kingdom, OL1 2JH
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Queen Alexandra Hospital Recruiting
Portsmouth, United Kingdom, PO6 3LY
Jessop Wing Recruiting
Sheffield, United Kingdom, S10 2SF
Princess Anne Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Chiesi UK
Leeds Teaching Hospitals NHS Trust
Imperial College London
Investigators
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Principal Investigator: Kevin Goss, MBBS Leeds Teaching Hospitals NHS Trust

Additional Information:
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Responsible Party: Chiesi UK
ClinicalTrials.gov Identifier: NCT03808402     History of Changes
Other Study ID Numbers: IRAS 237111
36652 ( Other Identifier: CPMS )
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chiesi UK:
Surfactant
Less Invasive Surfactant Administration
Mechanical Ventilation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Bronchopulmonary Dysplasia
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Ventilator-Induced Lung Injury
Lung Injury
Pulmonary Surfactants
Respiratory System Agents