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Evaluation of early and combined treatment with surfactant and inhaled nitric oxide in newborns with respiratory failure and pulmonary hypertensio

Not Applicable
Completed
Conditions
eonatal hypoxic respiratory failure and pulmonary hypertension
Neonatal 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
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
<br> 1. Proportion of infants requiring ECMO or death recorded during hospital stay<br> 2. Oxygen and ventilatory requirements recorded during hospital stay<br>
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