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Clinical Trials/ISRCTN13727958
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

Pontificia Universidad Católica de Chile0 sites100 target enrollmentSeptember 6, 2019

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)

Registry
who.int
Start Date
September 6, 2019
End Date
July 31, 2015
Last Updated
5 years ago
Study Type
Interventional
Sex
All

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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