Brief Title
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
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.
Study Type
Observational
Primary Outcome
Need for mechanical ventilation
Secondary Outcome
Survival
Condition
Respiratory Distress Syndrome
Study Arms / Comparison Groups
High dose surfactant
Description: Infants who receive a first dose of surfactant between 170 and 200 mg/kg
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
2900
Start Date
October 26, 2018
Completion Date
December 31, 2021
Primary Completion Date
December 31, 2021
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Kevin Goss, MBBS, 00441614885555, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT03808402
Organization ID
IRAS 237111
Secondary IDs
36652
Responsible Party
Sponsor
Study Sponsor
Chiesi UK
Collaborators
The Leeds Teaching Hospitals NHS Trust
Study Sponsor
Kevin Goss, MBBS, Principal Investigator, Leeds Teaching Hospitals NHS Trust
Verification Date
February 2021