Fast Assessment of Surfactant Deficiency in Preterm Infants to Speed up Treatment - Validation Study

NCT05615428 | Completed

• 1 other identifier: H-22007105 Validation Study
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 3

Brief Summary

The aim is to re-validate a FTIR spectroscopy test for measuring lung maturity/Respiratory Distress Syndrome (RDS) before conducting a RCT using this test to guide surfactant treatment of preterm infants. The test has been validated previously (NCT03235882) but needs re-validation due to continued improvement in accuracy and since the test is now developed into a Point of Care test (POC-test). The purpose is to accurately predict RDS using Lecithin/Sphingomyelin ratio (L/S ratio determined by a rapid FTIR in a newly developed point of care test (POC-test) on fresh gastric aspirates using retrospective analysis. The FAST 2 Validation Study is a part of the FAST 2 Trial consisting of a validation study and a subsequent randomized clinical trial, that will be registered separately on clinicaltrials.gov (NTC XXXXXXXXX)

Conditions

Surfactant Deficiency Syndrome Neonatal; Respiratory Distress Syndrome in Premature Infant

Keywords

surfactant replacement therapy; surfactant assay

Outcome Measures

Primary Outcomes (1)

• LS-ratio cut-off

  The primary objective is to measure the L/S-ratio in fresh GAS using the AIMI 1.0/2.0 L/S POC Device and compare the L/S-ratio with the need for surfactant treatment aiming to validate the previously defined cut-off L/S-ratio for surfactant treatment and to determine if the cut-off L/S ratio needs adjustment before starting FAST 2 RCT

  5 days

Study Arms (1)

observational group

Inclusion criteria: * GA ≤29+6, inborn at a participating centre * Age less than 45 minutes as gastric aspirate must be sampled within 45 minutes from delivery. Exclusion criteria: * Treated with surfactant beforerandomisation and obtaining gastric aspirates * Diagnosis of major malformations (major congenital heart defects, congenital diaphragmatic hernia, gastroschisis/omphalocele, pulmonary abnormalities including pulmonary hypoplasia and trachea-oesophageal fistula * Antenatal suspicion of significant oligohydramnios and lung hypoplasia * Any intrauterine intervention except if done for genetic testing

Diagnostic Test: LS-ratio

Interventions

LS-ratio DIAGNOSTIC_TEST

Included infants will have a gastric aspirate sampled via an NG tube at birth. This sample will be analyzed to determine the LS-ratio The LS-ratio will retrospectively be compared to RDS development and need for surfactant treatment to establish the cut-off ratio for LS-ratio with respect to surfactant treatment.

observational group

Eligibility Criteria

• Age: Up to 45 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm newborn babies that have gastric secretions sampled before 45 minutes of age.

You may qualify if:

• GA ≤29+6, inborn at a participating centre Age less than 45 minutes as gastric aspirate must be sampled within 45 minutes from delivery.

You may not qualify if:

• Treated with surfactant beforerandomisation and obtaining gastric aspirates
• Diagnosis of major malformations (major congenital heart defects, congenital diaphragmatic hernia, gastroschisis/omphalocele, pulmonary abnormalities including pulmonary hypoplasia and trachea-oesophageal fistula
• Antenatal suspicion of significant oligohydramnios and lung hypoplasia
• Any intrauterine intervention except if done for genetic testing

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Odense University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Holbaek Sygehus: collaborator

Study Sites (3)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gastric aspirate from newborn infants

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Christian Heiring

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: February 16, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 7, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DK (3)