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

NCT05638568 | Withdrawn

• 1 other identifier: H-22007105 RCT Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

Recently the investigators have developed a point of care test (LS-test) to measure surfactant as lecithin in gastric aspirates from preterm infants. This test can be done immediately at delivery and potentially be used to guide surfactant treatment. To obtain evidence-based knowledge on harms and benefit of surfactant therapy guided by the L/S test, a randomized clinical trial with relevant clinical short-and long-term outcomes needs to be performed, which is why the FAST 2 Trial has been designed.

Conditions

Surfactant Deficiency Syndrome Neonatal; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia

Keywords

surfactant assay; surfactant replacement therapy

Outcome Measures

Primary Outcomes (1)

• Survival without moderate to severe bronchopulmonary dysplasia (BPD)

  BPD is defined as per a modified "NIH definition" in which any degree of respiratory support for at least 28 days is considered equal to the need for oxygen: * Treatment with oxygen \> 21% or any degree of respiratory support for a least 28 days plus * Need for treatment with oxygen \> 21% or any degree of respiratory support at PMA 36 weeks or at discharge, whichever comes first. Definitions: * Moderate BPD is defined as treatment with oxygen \> 21% or any degree of respiratory support for a least 28 days plus need of supplemental oxygen from \>21% to \< 30% (as low flow O2) at 36+0 weeks PMA * Severe BPD is defined as treatment with oxygen \> 21% or any degree of respiratory support for a least 28 days plus need of \> 30% oxygen and/or continuous need for any level of respiratory support providing positive airway pressure (nHFT, nCPAP, NIV or mechanical ventilation)

  at 36 weeks PMA or discharge withever comes first

Secondary Outcomes (13)

• mortality

  From date of birth until the date of death if this happens before discharge

• Bronchopulmonary dysplasia

  at 36 weeks PMA or discharge withever comes first

• LS-ratio

  72 hours

• Nectrotizing enterocolitis

  From date of birth to 44 weeks of gestational age (usually around 18 weeks)

• Spontaneous intestinal perforation

  From date of birth to 44 weeks of gestational age (usually around 18 weeks)

Study Arms (2)

Intervention arm LS guided treatment

EXPERIMENTAL

all participating infants will have a gastric aspirate (GAS) sampled at birth within 45 minutes of life. The GAS will be analyzed immediately at the bedside by a LS-test POC device. For infants allocated to the interventional group the LS-result will be displayed as "treat with surfactant" or " do not treat with surfactant" depending on wether the LS-ratio is under or above the cut-off ratio for treatment. Those with LS-ratio above the cut-off ratio will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 \> 0.30) - ie same as in control group.

Diagnostic Test: LS test

Control arm - routine surfactant treatment

NO INTERVENTION

all participating infants will have a gastric aspirate (GAS) sampled at birth within 45 minutes of life. The GAS will be analyzed immediately at the bedside by a LS-test POC device, but result will remain blinded. Infants allocated to the control group will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 \> 0.30). The LS-ratio for those infants will remain blinded

Interventions

LS test DIAGNOSTIC_TEST

If the LS test indicated surfactant deficiency based on the cut off ratio early surfactant treatment will be done for patients in the intervention group If the LS test indicated no surfactant deficiency routine surfactant treatment will be done as per European RDS guidelines based on oxygen requirement (FiO2 \> 0.30)

Intervention arm LS guided treatment

Eligibility Criteria

• Age: Up to 45 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Treated with surfactant before randomisation 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 (4)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus Universtity Hospital

Aarhus, 8200, Denmark

Location

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Distress Syndrome; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventilator-Induced Lung Injury; Lung Injury

Study Officials

• Christian Heiring

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to blind LS-guided surfactant treatment in the interventional group, but the actual result of the LS-test will remain blinded for both groups until completion of the study except for as detailed above.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: all participating infants will have a gastric aspirate (GAS) sampled at birth within 45 minutes of life. The GAS will be analyzed bedside by a LS-test POC device. For infants allocated to the interventional group the LS-result will be displayed as "treat with surfactant" or " do not treat with surfactant" depending on wether the LS-ratio is under or above the cut-off ratio for treatment. Those with LS-ratio above the cut-off ratio will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 \> 0.30) Infants allocated to the control group will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 \> 0.30). The LS-ratio for those infants will remain blinded

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: December 6, 2022
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 7, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol will be published in peer reviewed journal as soon as possible SAP will be ublished in peer reviewed journal as soon as possible and prior to completion of primary data collection

Locations

DK (4)