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Clinical Trials/NL-OMON33002
NL-OMON33002
Withdrawn
Not Applicable

Mechanical ventilation comparing high versus low tidal volumes in infants with or without acute lung injury. - Mechanical ventilation comparing high versus low tidal volumes in infants.

niversitair Medisch Centrum Sint Radboud0 sites36 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Innate immuunresponse
Sponsor
niversitair Medisch Centrum Sint Radboud
Enrollment
36
Status
Withdrawn
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Sint Radboud

Eligibility Criteria

Inclusion Criteria

  • 1\. Children between the age of 2 months and 2 years admitted to the PICU and requiring MV with ALI and non ALI.
  • ALI is defined as:
  • \- Bilateral infiltration seen on frontal chest radiograph
  • \- No clinical evidence of left atrial hypertension
  • \- Partial pressure of oxygen (PaO2\)/fraction of inspired oxygen (FiO2\) ratio of less than 300 mmHg
  • 2\. Patients on ventilatory support not exceeding 72 hours before inclusion of the study.
  • 3\. The expected duration of ventilation should be minimal 24 hours.
  • 4\. Patients should be ventilated by the Pressure Regulated Volume Controle (PRVC) mode.

Exclusion Criteria

  • No informed consent from the patient\*s legal representative
  • Expected survival \< 2 days
  • Infants \< 2 months of age and infants \> 2 years
  • Use of corticosteroids \< 6 weeks before the start or during the study
  • Immunocompromised patients
  • Critical pulmonary or cardiac function documented by an FiO2/PaO2 ratio
  • \< 100 mmHg or need of catecholamines for inotropic support
  • defined as norepinephrine \> 0\.5 microgram/kg/min in spite of adequate fluid
  • resuscitation
  • Pneumothorax proven by chest X\-ray.

Outcomes

Primary Outcomes

Not specified

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