A study about the use of whole body cooling for severe respiratory distress due to meconium aspiration syndrome (MAS) in neonates
Completed
- Conditions
- Meconium aspiration syndromeNeonatal DiseasesNeonatal aspiration of meconium
- Registration Number
- ISRCTN10541833
- Lead Sponsor
- Individual sponsor (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 0
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
1. Major congenital malformation or known chromosomal abnormalities
2. Any lung disease other than MAS
3. Need for extra-corporeal membrane oxygenation (ECMO)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gas exchange over the first 72 hours of life (as described by oxygenation index, PaCO2 and pH)
- Secondary Outcome Measures
Name Time Method 1. Duration of invasive mechanical ventilation<br>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)<br>3. Length of stay in the intensive care unit<br>4. Length of hospital stay