Meconium aspiration syndrome Neonatal Diseases Neonatal aspiration of meconium
Conditions
Interventions
The intervention being tested is whole body hypothermia. There are interesting animal and translational data suggesting the usefulness of whole body hypothermia for some forms of respiratory failure a
Sponsors
Individual sponsor (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study cohort consisted of MAS neonates treated with WBH according to the TOBY trial criteria (see above). Control cohort consisted of MAS babies in whom TOBY criteria were not met and WBH was not instigated. All babies had to fulfill the following MAS diagnostic criteria: 1. Meconium-stained amniotic fluid 2. Need for intubation and tracheal suctioning in the delivery room according to the American Academy of Pediatrics neonatal resuscitation guidelines 3. Typical chest radiograph appearance 4. Oxygenation index (OI) > 10 at the intensive care unit admission
Exclusion criteria
Exclusion criteria: 1. Major congenital malformation or known chromosomal abnormalities 2. Any lung disease other than MAS 3. Need for extra-corporeal membrane oxygenation (ECMO)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gas exchange over the first 72 hours of life (as described by oxygenation index, PaCO2 and pH) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of invasive mechanical ventilation 2. Total duration of respiratory support (defined as the total time spent under invasive, non-invasive ventilation, continuous positive airway pressure/high flow nasal cannulae and free oxygen therapy) 3. Length of stay in the intensive care unit 4. Length of hospital stay | — |
Countries
Australia, Brazil, France, Italy, Netherlands, Spain, United Kingdom, United States of America
Outcome results
None listed