Prematurity Clinical Trial
— FASTOfficial title:
Fast Assessment of Surfactant Deficiency to Speed up Treatment: Assessment of Lung Maturity and Prediction of RDS by Determination of L/S-ratio in Fresh Gastric Aspirates by FTIR Spectroscopy
NCT number | NCT03235882 |
Other study ID # | H-17013993 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | April 26, 2019 |
Verified date | March 2020 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 using Lecithin/Sphingomyelin ratio (L/S ratio
determined by a rapid FTIR test on fresh gastric aspirates) using retrospective analysis.
Research question:
"In very preterm newborn infants with (risk of) respiratory distress who have not received
prophylactic surfactant: does analysis of L/S-ratio in fresh gastric aspirates using a rapid
FTIR test predict RDS requiring exogenous surfactant with sufficient specificity and
sensitivity to be clinical useful?
Status | Completed |
Enrollment | 72 |
Est. completion date | April 26, 2019 |
Est. primary completion date | April 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 45 Minutes |
Eligibility |
Inclusion Criteria: 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Neonatology, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Aalborg University Hospital, Aarhus University Hospital, Herlev Hospital, Holbaek Sygehus, Hvidovre University Hospital, Kolding Sygehus, Odense University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | development of RDS | 5 days from delivery |
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