NCT01304654

Brief Summary

Identify pediatric oncologic patients with ALI/ARDS at GRAACC (Grupo de Apoio ao Adolescente e a Criança com Câncer) /IOP's (Instituto de Oncologia Pediátrica) Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Typical duration 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

Study Start

First participant enrolled

January 8, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2013

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2013

Enrollment Period

2.2 years

First QC Date

February 24, 2011

Last Update Submit

March 10, 2025

Conditions

Acute Lung InjuryAcute Respiratory Distress SyndromeNeoplasms

Keywords

acute lung injuryrespiratory distress syndromeneoplasmschild

Outcome Measures

Primary Outcomes (1)

  • Identify pediatric oncologic patients with ALI/ARDS at GRAACC's PICU and evaluate how they are mechanically ventilated

    2y

Secondary Outcomes (1)

  • Epidemiologic data about the selected patients

    28 days

Study Arms (1)

ALI/ARDS oncologic patients

Consecutively admitted patients at GRAACC's PICU with malignancy diagnosis according to IDC-10, in a 24mo consecutive period, under mechanical ventilation for over 24h and with ALI/ARDS criteria, not younger than 29 days or older than 17 years 11 months

Eligibility Criteria

Age29 Days - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric oncologic patients

You may qualify if:

  • patients admitted at the intensive care unit with diagnosis of acute lung injury or acute respiratory distress syndrome and submitted to mechanical ventilation for over 24h

You may not qualify if:

  • mechanical ventilation less than 24h
  • absence of ALI/ARDS criteria
  • no neoplasm diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grupo de Apoio ao Adolescente e à Criança com Câncer

São Paulo, São Paulo, 04023-062, Brazil

Location

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress SyndromeNeoplasms

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Rodrigo G Arduini, MD

    Grupo de Apoio ao Adolescente e a Crianca com Cancer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

January 8, 2011

Primary Completion

March 30, 2013

Study Completion

June 15, 2013

Last Updated

March 13, 2025

Record last verified: 2013-03

Locations

BR(1)