Evaluation of early and combined treatment with surfactant and inhaled nitric oxide in newborns with respiratory failure and pulmonary hypertensio
- Conditions
- eonatal hypoxic respiratory failure and pulmonary hypertensionNeonatal Diseases
- Registration Number
- ISRCTN13727958
- Lead Sponsor
- Pontificia Universidad Católica de Chile
- Brief Summary
2020 results in https://doi.org/10.1038/s41372-020-00777-x (added 26/08/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1. Near term infants (35 weeks gestation) with birth weights > 2000 g and who are less than 72 hours old
2. Infants requiring mechanical ventilation with hypoxemic respiratory failure with an OI > 20, calculated on two consecutive measurements of post ductal arterial blood gases without acidosis (pH > 7.25) and efforts will be done to adjust ventilatory support to reach a PCO2 < 60
3. A previous echocardiogram will be performed to rule out a cardiac anomaly and evaluate the presence of pulmonary hypertension (a tricuspid insufficiency jet with an estimated systolic pulmonary artery pressure = 2/3 of systemic systolic arterial blood pressure and/or evidence of right-to-left shunting through foramen ovale or ductus arteriosus)
1. Life-threatening congenital anomalies
2. Congenital heart disease
3. Congenital diaphragmatic hernia
4. Other forms of lung hypoplasia syndromes
5. Suspected or confirmed chromosomal abnormality
6. Postnatal age > 72 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of infants developing treatment failure during the first 48 hours of study treatment, defined as an oxygenation index (OI) = 40
- Secondary Outcome Measures
Name Time Method <br> 1. Proportion of infants requiring ECMO or death recorded during hospital stay<br> 2. Oxygen and ventilatory requirements recorded during hospital stay<br>