Fast Assessment of Surfactant Deficiency to Speed up Treatment

NCT03235882 | Completed

• 1 other identifier: H-17013993
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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 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?

Conditions

RDS of Prematurity; Prematurity

Keywords

Lung surfactant; Mid-infrared spectroscopy; Prematurity; Respiratory distress syndrome; gastric aspirate

Outcome Measures

Primary Outcomes (1)

• development of RDS

  5 days from delivery

Study Arms (1)

observational group

Infants born 24-32 weeks. Inclusion criteria: * Have gastric aspirate and oral secretions 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

Diagnostic Test: LS-ratio

Interventions

LS-ratio DIAGNOSTIC_TEST

Accurately predict RDS using Lecithin/Sphingomyelin ratio (L/S ratio determined by a rapid FTIR test on fresh gastric aspirates) using retrospective analysis

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/oral secretions sampled before 45 minutes of age

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Links

• Publication of the completed study

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants; Premature Birth; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: September 1, 2017
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

DK (1)