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

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie	Rzeszow	Poland
Szpital Specjalistyczny Im. Swietej Rodziny SPZOZ	Warsaw	Poland
Szpital Specjalistyczny Nr 2 W Bytomiu	Bytom	Poland

Other Sites

Site Name	City	Country
Szpital Kliniczny Im. Ks. Anny Mazowieckiej samodzielny publiczny zakład opieki zdrowotnej	Warsaw	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Sbpwzgz Uirwdhwcebugi Idwgtpx Kvnpdw Mptbjsulxvxodbp W Zdlxjebb Gekoj Stt z oe ov	Zielona Gora	Poland
Gnzwgcnuniaqzz Pciugmipxf Sudvzzj Kfavinkdu Udizcdjlzurl Mjtfycdlcr Ih Kuqnwh Mbvsppdbpglzrpp W Pbqyvboh	Poznan	Poland
Svfagnl Scyqbwslztyyfrp Pascdsweclu Tazgem Lcqxehfi sjogc	Rzeszow	Poland
Uzytqteqmsjjg Scclpna Kqtwtrqco Nv 2 Pqz W Sanjbvbqfz	Szczecin	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.09.2021

Trial locations

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.

Investigated diseases:

Neonatal respiratory failure

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.

Trial ID:

2024-515216-46-00

Protocol code:

REFSAL

Trial Phase:

Human Pharmacology (Phase I) – Other

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

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