NCT02449863

Brief Summary

Neonatal respiratory distress prognosis may be difficult to estimate at admission. Lung ultrasound is a useful diagnostic tool that is quick, requires little training and is radiation free. This study analyzes whether early lung ultrasound can predict respiratory failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

May 18, 2015

Last Update Submit

May 19, 2015

Conditions

Ultrasonic Diagnosis

Keywords

Lung ultrasoundMechanical ventilationRespiratory distress syndromeTransient tachypnea of the newborn

Outcome Measures

Primary Outcomes (1)

  • investigate whether LUS performed during the first 2 hours of life is a useful tool to predict respiratory failure of neonates older than 32 weeks with respiratory distress

    2 hours of life

Study Arms (2)

Low risk ultrasound

Patients with a low risk ultrasound

Other: Lung ultrasound

High risk ultrasound

Patients with a high risk ultrasound

Other: Lung ultrasound

Interventions

Lung ultrasoundOTHER

Lung ultrasound performed to newborns with respiratory distress

High risk ultrasoundLow risk ultrasound

Eligibility Criteria

Age32 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older than 32 weeks admitted to the neonatal intensive care unit with respiratory distress who were not on invasive mechanical ventilation (MV) were eligible for recruitment.

You may qualify if:

  • \- Patients older than 32 weeks admitted to the neonatal intensive care unit with respiratory distress who were not on invasive mechanical ventilation (MV) were eligible for recruitment.

You may not qualify if:

  • Patients younger than 32 weeks
  • Patients with mechanic ventilation ar admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Sant Joan de Déu

Esplugues de Llobregat, Spain

Location

Javier Rodriguez Fanjul

Esplugues de Llobregat, Spain

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeTransient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersRespiratory Distress Syndrome, NewbornTachypneaInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Javier Rodríguez-Fanjul, M.D.

    Hospital Sant Joan de Déu. Esplugues de Llobregat. Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 20, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

ES(2)