ISRCTN13727958
Completed
未知
Randomized controlled trial to assess the early addition of exogenous surfactant to inhaled nitric oxide in the treatment of newborns with respiratory failure and pulmonary hypertension
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- eonatal hypoxic respiratory failure and pulmonary hypertension
- Sponsor
- Pontificia Universidad Católica de Chile
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2020 results in https://doi.org/10.1038/s41372-020-00777-x (added 26/08/2020)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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