Determination of Lung Maturity and Prediction of RDS at B... | NCT02076126

Studies
Determination of Lung Maturity and Prediction of RDS at Birth

NCT02076126

Sponsor

Henrik Axel Verder

Status

Completed

Last Update Posted

Jan 30, 2015Estimated

Enrollment

145Actual

Phase

Not provided

Conditions

RDS
Premature Birth

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Feb 28, 2014

First Submission Date that Met QC Criteria

Feb 28, 2014

First Posted Date

Mar 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2015

Last Update Posted Date

Jan 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Henrik Axel Verder, Professor DMSc, Holbaek SygehusSponsor-Investigator

Lead Sponsor

Henrik Axel VerderOTHER

Collaborators

Name	Class
Holbaek Sygehus	OTHER
Aalborg University Hospital	OTHER
Odense University Hospital	OTHER
Aarhus University Hospital Skejby

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In at least 135 preterm infants with gestational age 24-32 weeks we will collect gastric aspirate and hypopharyngeal secretion. The infants are stratified into three groups: gestational age 24-25 weeks, 26-29 weeks and 30-31 weeks.

The aspirates will be frozen at -20 centigrade and lecithin-sphingomyelin ratio (L/S) will be analysed retrospectively using Fourier Transform Infrared Spectroscopy.

The infants will be monitored for the first five days with regard to possible development of RDS.

Clinical and biochemical data will be compared retrospectively.

There a no intervention procedures.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Measure	Description	Time Frame
RDS		5 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Lack of informed consent
lack of aspirate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

30 Minutes

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik Verder, Professor MD	Holbaek Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holbaek Sygehus		Holbæk		4300	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided