Pulmonary Hypertension of the newborn
Conditions
Interventions
Treatment of Pulmonary Hypertension (PHT)in the newborns who had the following criteria:
Diagnostic criteria of PHT: 1. generalized cyanosis confirmed by oxygen saturation (SatO2) under 85 % which wa
2. pre and postductal saturation gradient more than 5%, without echocardiographic evidence of structural congenital cardiopathy and echocardiographic evidence of PHT
3. direct signs of PHT by measuring PAP and/or indirect signs of PHT as tricuspid insufficiency, blood flow through permeable ductus arteriosus or oval foramen from right to left, rectification of the
Device
E05.318.308.980
I01.880.604.473.352.500.030.500
Sponsors
Hospital de Clínicas
Consejo Nacional de Innovación, Ciencia y Tecnología (CONICYT)
Hospital de Clínicas
Eligibility
Age
0 Days to 30 Days
Inclusion criteria
Inclusion criteria: Written parental consent to receive the proposed therapy; newborns greater than 34 weeks of gestational age; diagnostic of severe refractory hypoxemia receiving conventional intensive care supporting treatment; no access to any other kind of inhaled Nitric Oxide therapy; oxygenation index over 10; pre and post-ductal difference in pulsioximetry equal or over 5
Exclusion criteria
Exclusion criteria: Neonates with multiple malformations or malformations incompatible with extra uterine life. Lack of parental consent to receive the proposed therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Decrease in the oxygenation index between the time before the start of nitric oxide therapy and the first 24 hours after at least in 5 patients. 2. The respiratory parameters were evaluated 3 hours before and 3 hours after exposure to NO administered by TAS + PLUS.;1.The main result, a decrease in the oxygenation index after exposure to NO produced by TAS + PLUS, was observed after 3 hours starting from a mean of 24 and reaching an average of 17 in 3 hours, being statistically significant. 2.SatO2 and PaO2 increased significantly after treatment. SatO2 was 88 (± 9, average and DS) 3 h before the start of nitric oxide and 93 (± 8) 3 h after PaO2 was 55 (± 23, mean and SD) 3 hours before the start of nitric oxide and 99 (± 66) 3 hours after | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Survival after the use of the generator of the nitric oxide generator in situ next to the bed of the patient, assessed at hospital discharge;1. 19 patients survived and 13 patients died prior to hospital discharge | — |
Countries
Uruguay
Contacts
Public ContactMaria Fernanda Viera
Hospital de Clínicas
Outcome results
None listed