Single-dose dexamethasone and/or bronchoalveolar lavage with diluted surfactant in the treatment of severe meconium aspiration syndrome - SAMDEXSUR

• Conditions: Severe meconium aspiration syndrome

• Registration Number: EUCTR2005-002687-29-ES
• Lead Sponsor: XAVIER CARBONELL ESTRANY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

In order for a patient to be eligible for inclusion in the study, the following criteria must be met:
1-Diagnosis of MAS, based on the following criteria:
·Meconium stained amniotic fluid, plus
·Early breathing difficulty (in the first 2 hours of life), with
·X-ray findings compatible with MAS, and
·Aspiration of meconium from the trachea at birth or at the time of intubation
2-Gestational age > 36 weeks and weight > 2 kg
3-Intubated, ventilated and with OI > 10 in the first 4 hours of life.
4-Signed informed consent from the parents

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:
1- NI with severe hypoxic-ischemic encephalopathy (grade III)
2- NI with major congenital abnormalities
3- Congenital heart disease
4- Severe early sepsis with shock and/or disseminated intravascular coagulation (DIC)
5- OI > 40 (ECMO)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified