Severe meconium aspiration syndrome
Conditions
Interventions
Trade Name: SURVANTA
Pharmaceutical Form: Endotracheopulmonary instillation, suspension
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Trade Nam
Sponsors
XAVIER CARBONELL ESTRANY
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy of two treatment regimens: bronchoalveolar lavage with diluted surfactant and bronchoalveolar lavage with diluted surfactant plus single-dose and early dexamethasone versus conventional treatment, in full-term infants (FTI) with meconium aspiration syndrome (MAS), in the context of a controlled randomized study. The primary objective will be reduction of the oxygenation index by more than 30% twenty-four hours after lavage. ;Secondary Objective: The secondary objectives will comprise reduction in mortality, pneumothorax, duration of invasive ventilation, duration of continuous positive airway pressure (CPAP) treatment, oxygen therapy and days of hospitalization.;Primary end point(s): Primary endpoint · Improvement in OI = 30% twenty-four hours after lavage Secondary endpoints · Hours of invasive ventilation · Hours of CPAP · Mortality · Pneumothorax · Hours of oxygen therapy · Days of hospital stay · Hours of HFOV · Hours of iNO Safety endpoints · Changes in Sat O2 during lavage · Changes in mean blood pressure during and after lavage · Changes in pH, PCO2 and EB after lavage · Pneumothorax and lung hemorrhage after lavage · Control of corticoid side effects: digestive bleeding, hyperglycemia, increased blood pressure | — |
Countries
Spain
Outcome results
None listed