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Evaluation of frequency occurrence persistent pulmonary hypertension of newborns treated by salbutamol
EU CTIS ID: 2024-515216-46-00
What this study is testing
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%
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
- 9. Necessity for surfactant administrating directly after birth regardless of the method of administration (respiratory distress syndrome - RDS).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.