The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS

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Bronchopulmonary dysplasia
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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

2973

Start Date

October 26, 2018

Completion Date

September 30, 2021

Primary Completion Date

September 30, 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, ,

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 2022