Status:
COMPLETED
Fast Assessment of Surfactant Deficiency to Speed up Treatment
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Aalborg University Hospital
Aarhus University Hospital
Conditions:
RDS of Prematurity
Prematurity
Eligibility:
All Genders
Up to 45 years
Brief Summary
The aim is to validate a FTIR spectroscopy test for measuring lung maturity/Respiratory Distress Syndrome (RDS) in terms of safety, usability, and efficacy. The purpose is to accurately predict RDS u...
Detailed Description
Respiratory distress syndrome (RDS) remains a major cause of mortality and morbidity in premature infants despite the increased use of antenatal steroids and early nasal continuous positive airway pre...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Have GAS obtained within 45 minutes from birth via:
- a naso- or orogastric tube inserted in the delivery room if clinically indicated as part of resuscitation or
- a nasogastric tube inserted as part of routine management of preterm infants.
- Written informed consent has been obtained
Exclusion
- Intubated and treated with surfactant before obtaining GAS
- Diagnosis of lethal malformations
- Antenatal diagnosis of lung hypoplasia
- Therapeutic infusion given in the amniotic cavity
- GAS unavailable or significantly contaminated by meconium/pus
- Sepsis
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 26 2019
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03235882
Start Date
September 1 2017
End Date
April 26 2019
Last Update
March 16 2020
Active Locations (1)
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1
Department of Neonatology, Rigshospitalet
Copenhagen, Denmark, 2100