Evaluation of frequency occurrence persistent pulmonary hypertension of newborns in group of newborns born between 32 and 42 weeks of pregnancy treated by salbutamol - REFSA

Warszawski Uniwersytet Medyczny0 个研究点目标入组 608 人开始时间: 2020年12月7日最近更新: 2024年7月22日

适应症

试验速览

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•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.
•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

•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).

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