Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

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

This study is investigating a lung condition called persistent pulmonary hypertension of the newborn (PPHN) in babies born between 32 and 42 weeks of pregnancy. Researchers are interested in how often this condition occurs in newborns who are treated with a medicine called salbutamol due to breathing difficulties. PPHN is a serious condition where the blood vessels in the lungs don't open up properly after birth, making it hard for the baby to get enough oxygen. The study aims to understand the frequency of PPHN in these babies when salbutamol is used for their breathing problems. They will be looking at how much oxygen the babies need and using tests like heart scans to detect PPHN. The overall goal is to learn more about how different treatments affect newborn breathing.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Medical University Of Warsaw

Enrolment target

608

Start

16 Dec 2024

Breathing disorders as a cause of neonatal respiratory failure

What is this study about?

This study is about a breathing problem called persistent pulmonary hypertension of the newborn (PPHN) that can affect babies soon after they are born. PPHN happens when the blood vessels in a baby's lungs don't open up properly after birth. This makes it difficult for the baby to get enough oxygen into their blood, which can be very serious.

Researchers are looking at a group of babies born between 32 and 42 weeks of pregnancy who are having breathing difficulties. These babies might be given a medicine called salbutamol to help them breathe. The study wants to find out how often PPHN occurs in these babies when they are treated with salbutamol.

They will be carefully checking if babies need a lot of extra oxygen or if heart scans show signs of high pressure in their lungs. By understanding how often PPHN happens in these situations, doctors hope to learn more about how to best care for newborns with breathing problems and improve their outcomes.

Key takeaways

Study examines PPHN in newborns with breathing difficulties.
Focuses on babies treated with salbutamol.
Aims to understand how often PPHN occurs in this group.
Involves close monitoring, including heart scans and oxygen levels.
Participation will help doctors learn more about newborn breathing conditions.

Who may be eligible?

This study is designed for newborn babies who are experiencing breathing problems. It includes babies born from 32 weeks of pregnancy up to the full term of 42 weeks.

Both baby boys and baby girls can take part in this research. The main requirement is that the baby has breathing difficulties for which they might receive treatment, such as salbutamol.

The research team will assess if a newborn meets all the necessary criteria to ensure the study is safe and appropriate for them.

Quick self-check

Is your baby a newborn?
Was your baby born between 32 and 42 weeks of pregnancy?
Is your baby currently experiencing breathing problems?
Has your baby's doctor suggested salbutamol for their breathing?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your baby is eligible to take part in this study, they will receive either the study medicine, salbutamol, or a dummy medicine (placebo) that looks identical but contains no active drug. This is given as a liquid. Doctors will closely monitor your baby's breathing and overall health. They will check things like how much oxygen your baby needs and perform tests like heart scans (echocardiograms) to look at their lungs. They will also take blood samples to check their acid-base balance and other important levels. The medical team will note how long your baby needs help with breathing, how long they stay in hospital, and if any side effects occur. The total duration of participation will depend on your baby's recovery and hospital stay.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For your baby, the potential benefit is closer monitoring by a dedicated medical team, which might help us understand their breathing condition better. However, there could be risks associated with receiving any medication, including salbutamol, such as potential side effects. There is also no guarantee that your baby's condition will improve by being in the study. You have the right to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

—
Poland

Common questions

What is PPHN?

PPHN stands for Persistent Pulmonary Hypertension of the Newborn. It's a condition where a baby's heart and lung circulation doesn't adapt properly after birth, making it hard for them to get enough oxygen.

What is salbutamol?

Salbutamol is a medicine often used to help open up the airways and make breathing easier. It's commonly used for conditions like asthma.

Will my baby get the actual medicine or a dummy one?

In this study, your baby will either receive salbutamol or a dummy medicine (placebo). This is done randomly, and neither you nor the doctors will know which one your baby is getting to ensure fair results.

How long will my baby be monitored?

Your baby will be monitored throughout their hospital stay, especially while they are experiencing breathing difficulties and receiving study treatment. The exact duration will depend on their medical needs.

What if I change my mind about my baby participating?

You are free to change your mind and withdraw your baby from the study at any time, for any reason. This will not affect the medical care your baby receives.