NCT02076126

Brief Summary

The overall objective is to identify quickly after birth the preterm infants who will develop respiratory distress syndrome (RDS) for the purpose of treating them as early as possible with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen treatment. We have therefore developed a quick test, which we believe will be ideal for this type of diagnostics, and will now test the method in a preclinical trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

February 28, 2014

Last Update Submit

January 29, 2015

Conditions

RDSPremature Birth

Keywords

Lung maturityRDSPrematurityLecithin-sphingomyelin ratioSpectroscopyChemometrics

Outcome Measures

Primary Outcomes (1)

  • RDS

    5 days

Study Arms (2)

Gastric aspirate

L/S ratio on the gastric aspirates are retrospectively compared with the possible development of RDS

Hypopharyngeal secretion

L/S ratio on the hypopharyngeal secretions are retrospectively compared with the possible development of RDS

Eligibility Criteria

Age1 Minute - 30 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

135 preterm infants with gestational age 24-32 weeks (24+0 to 31+6)

You may qualify if:

  • Preterm infants with gestational ages of 24 (24+0) to 32 (31+6) weeks.
  • Age \< ½ hour

You may not qualify if:

  • Lack of informed consent
  • lack of aspirate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holbaek Sygehus

Holbæk, 4300, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gastric- and hypopharyngeal secretions

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Henrik Verder, Professor MD

    Holbaek Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor DMSc

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 3, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

DK(1)