Not recruiting

Study on Persistent Pulmonary Hypertension in Newborns Treated with Salbutamol and Sodium Chloride

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as persistent pulmonary hypertension of the newborn (PPHN), which affects the breathing of newborns. The study involves the use of a medication called salbutamol, which is commonly used to help with breathing issues. Salbutamol is administered through inhalation, meaning it is breathed in to help open up the airways in the lungs.

The purpose of the study is to evaluate how often PPHN occurs in newborns who are treated with salbutamol. The study will observe newborns who are born between 32 and 42 weeks of pregnancy and have breathing problems shortly after birth. These newborns may need help with breathing, such as ventilation, which is a method to assist with breathing using a machine. The study will monitor the newborns' breathing and other health indicators over a period of time to gather information on the effectiveness of salbutamol in treating PPHN.

During the study, researchers will assess various factors, including the need for additional oxygen, the duration of respiratory support, and the overall hospital stay. They will also look at the results of certain tests, such as the acid-base balance, which measures the levels of acids and bases in the blood, and the occurrence of any adverse events. The study aims to provide valuable insights into the treatment of PPHN in newborns using salbutamol.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, newborns are assessed to ensure they meet the eligibility criteria. This includes being born between 32 and 42 weeks of pregnancy and experiencing certain breathing difficulties shortly after birth.
A chest X-ray is performed within the first 6 hours of life, and an acid-base balance test is conducted using blood from the umbilical cord or a heel prick.
Step 2
Treatment administration
The treatment involves the use of salbutamol sulfate and sodium chloride, administered through inhalation. The specific dosage and frequency are determined by the medical team based on the newborn's condition.
The treatment aims to address breathing disorders that may cause respiratory failure in newborns.
Step 3
Monitoring and assessment
Throughout the trial, the newborn's condition is closely monitored. This includes assessing the need for ventilation with additional oxygen and checking for signs of increased pressure in the lungs.
Regular evaluations are conducted to measure the effectiveness of the treatment and to monitor for any adverse events.
Step 4
Completion of the trial
The trial continues until the estimated end date of December 31, 2025, or until the newborn no longer requires treatment.
Upon completion, the results are analyzed to determine the frequency of persistent pulmonary hypertension in newborns treated with salbutamol.

Who can join the trial?

5 criteria

Newborns must be born from a pregnancy lasting at least 32 weeks and 0 days and no longer than 41 weeks and 6 days.
Newborns must be screened for eligibility from birth until the inclusion criteria are met or until 24 hours after birth, whichever comes first.
Newborns must have breathing problems such as fast breathing or difficulty breathing that last for more than 15 minutes after birth, or these problems must occur within the first 6 hours of life for at least 15 minutes, or they must need breathing support at birth before the age of 6 hours.
A chest X-ray must be taken within the first 6 hours of life.
An acid-base balance (ABS) test must be performed using blood from the umbilical cord or a small blood sample taken from the heel of the newborn within the first hour of life. This test checks the levels of acid and base in the blood.

Who cannot join the trial?

4 criteria

Patients with **breathing disorders** that cause **neonatal respiratory failure** cannot participate. This means if a newborn has trouble breathing on their own, they are not eligible.
Patients who need **ventilation** with extra oxygen in the air they breathe, specifically if the oxygen level is more than 30%, are excluded. Ventilation is a machine that helps with breathing.
Patients showing signs of **increased pulmonary pressure** through an echocardiogram are not eligible. An echocardiogram is a test that uses sound waves to create pictures of the heart.
Patients with a difference in oxygen levels before and after the heart's duct of more than 10% are excluded. This refers to the difference in oxygen saturation levels in the blood.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
Rzeszow, Poland
Verified
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Cracow, Poland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Salbutamol is a medication commonly used to help open up the airways in the lungs, making it easier to breathe. It is often used to treat conditions like asthma or other breathing problems. In this clinical trial, salbutamol is being used to see if it can help newborns who have a condition called persistent pulmonary hypertension of the newborn (PPHN). This condition makes it hard for babies to get enough oxygen into their blood because the blood vessels in their lungs are too tight. By using salbutamol, the trial aims to see if it can help relax these blood vessels, improve breathing, and increase oxygen levels in the blood of these newborns.

What is already known about the treatment

Salbutamol – Salbutamol is administered as an inhalation or oral medication, commonly used to help with breathing problems. It is currently being studied for its effectiveness in treating breathing disorders in newborns, particularly those born between 32 and 42 weeks of pregnancy. The main therapeutic use of Salbutamol in this context is to address persistent pulmonary hypertension in newborns, a condition where the blood pressure in the lungs is too high. At the molecular level, Salbutamol works by relaxing the muscles in the airways, making it easier to breathe. It is classified as a bronchodilator, which means it helps open up the air passages in the lungs.

Investigated diseases

Persistent Pulmonary Hypertension of the Newborn (PPHN) – This condition occurs when a newborn's circulation system does not adapt to breathing outside the womb, leading to high blood pressure in the lungs. Normally, a baby's blood circulation changes after birth, allowing blood to flow to the lungs to pick up oxygen. In PPHN, this transition does not happen properly, causing blood to bypass the lungs and reducing oxygen levels in the bloodstream. The condition is characterized by the need for additional oxygen and signs of increased pressure in the pulmonary arteries. It can result in difficulty breathing and requires careful monitoring and management. The condition is often identified by specific echocardiographic features and differences in oxygen saturation levels before and after the ductus arteriosus.