Persistent pulmonary hypertension of newborns in group of newborns born between 32 and 42 weeks of pregnancy
Conditions
Interventions
Trade Name: Ventolin, 1 mg/ml (0,1%), nebulisation solution
Pharmaceutical Form: Nebulisation solution
Pharmaceutical form of the placebo: Nebulisation solution
Route of administration of the placebo:
Sponsors
Warszawski Uniwersytet Medyczny
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Screening / Eligibility criteria: Newborns born from a pregnancy lasting min. 32 0/7 and no longer than 41 6/7 weeks. Eligibility period from birth until the inclusion criteria are met or 24 hours are reached, whichever comes first. Inclusion criteria: Each Patient in the Study must meet all of the following inclusion criteria: 1. Disturbances of tachypnoe breathing and expiratory bulking persisting for more than 15 minutes after birth or the above mentioned respiratory disturbances occurring up to the age of 6 hours for at least 15 minutes or the need for breathing support at birth before the age of 6 hours 2. Newborns born from a pregnancy of at least 32 0/7 weeks to 41 6/7 weeks. 3. Chest X-ray image taken up to 6 hours of age. 4. Performed acid-base balance (ABS) test from umbilical cord blood or capillary blood drawn from the heel of a newborn in the first hour of life. Are the trial subjects under 18? yes Number of subjects for this age range: 608 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: If the Patient meets one of the following conditions cannot be included in the Study: 1. Need for intubation immediately after birth 2. Perinatal hypoxia defined on the basis of an abnormal acid-base balance (ABS) result from umbilical cord blood or capillary blood taken from the heel of a newborn in the first hour of life, with a pH < 7.0 or BE below -14 mmol/L. 3. Age over 24 hours from birth 4. Meconium aspiration syndrome 5. Neonatal air leak syndrome 6. Congenital heart defects 7. Congenital diaphragmatic hernia 8. Other severe congenital malformations and genetically determined syndromes associated with a higher risk of respiratory failure diagnosed before and after birth. 9. Necessity for surfactant administrating directly after birth regardless of the method of administration (respiratory distress syndrome - RDS).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of frequency occurrence PPHN defined as the need to use ventilation with an additional oxygen fraction in the respiratory mixture (FiO2)> 0.30 and echocardiographic features of increased pulmonary pressure (right - left or bi-directional leakage through an unobstructed arterial duct or oval opening) or the difference in pre- and post-ductal saturation > 10%;Secondary Objective: Evaluation on the TTN scale (modified Silverman score) in comparison to the concentration of oxygen used during ventilation and acid-base equilibrium parameters: pH, carbon dioxide pressure (pCO2) and alkaline deficiency (BE) in compared groups;Primary end point(s): Assessment of the incidence of PPHN defined as the need for ventilation with additional oxygen fraction in the respiratory mixture (FiO2) > 0. 30 and echocardiographic features of elevated pulmonary pressure or the difference in pre and postprandial saturation > 10% ;Timepoint(s) of evaluation of this end point: Echocardiographic examination during the observation period, i. e. Extended 48 hours from randomisation to 7 days of age or discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Scoring on the TTN score. 2. Prevalence of failures defined as the need for intubation 3. Duration of respiratory support 4. Hospitalisation time 5. Results of the acid-base balance (ABS) and ionogram 6. Occurrence of Adverse Events ;Timepoint(s) of evaluation of this end point: Treatment/observation period - II Period (24h to 48h from randomization), during the observation period to the Investigator decision. | — |
Countries
Poland
Contacts
Public ContactStudy Country Coordinator
Dr. hab. n. med. Renata Bokiniec / Warszawski Uniwersytet Medyczny
Outcome results
None listed