What is the purpose of this trial?Premature babies often need help immediately after birth to open their lungs to air, start breathing and keep their hearts beating. Opening their lungs can be difficult, and once open the under-developed lungs of premature babies will often collapse again between each breath. To prevent this nearly all premature babies receive some form of mechanical respiratory support to aid breathing. Common to all types of respiratory support is the delivery of a treatment called positive end-expiratory pressure, or PEEP. PEEP gives air, or a mixture of air and oxygen, to the lung between each breath to keep the lungs open and stop them collapsing.
Currently, clinicians do not have enough evidence on the right amount, or level, of PEEP to give at birth. As a result, doctors around the world give different amounts (or levels) of PEEP to premature babies at birth.
In this study, the Investigators will look at 2 different approaches to PEEP to help premature babies during their first breaths at birth. At the moment, the Investigators do not know if one is better than the other. One is to give the same PEEP level to the lungs. The others is to give a high PEEP level at birth when the lungs are hardest to open and then decrease the PEEP later once the lungs are opened and the baby is breathing.
Very premature babies have a risk of long-term lung disease (chronic lung disease). The more breathing support a premature baby needs, the more likely the risk of developing chronic lung disease. The Investigators want to find out whether one method of opening the baby's lungs at birth results in them needing less breathing support.
This research has been initiated by a group of doctors from Australia, the Netherlands and the USA, all who look after premature babies.
Will I have to stop taking my current medications?The trial information does not specify whether participants must stop taking their current medications.
What data supports the effectiveness of the treatment Positive End-Expiratory Pressure (PEEP) for premature birth?Research shows that PEEP, when used in nasal continuous positive airway pressure (CPAP), can reduce the need for more invasive breathing support in very low birth weight infants with breathing problems. However, finding the right PEEP level is crucial, as too little or too much can lead to complications.
12345 Is Positive End-Expiratory Pressure (PEEP) generally safe for use in humans?PEEP is generally used safely in newborns, infants, and children to help with breathing, but it can have complications like lung damage, decreased heart function, and increased pressure in the brain if not set correctly. It is important to tailor PEEP settings individually to minimize risks.
12567 How is the treatment PEEP different from other treatments for premature birth?PEEP (Positive End-Expiratory Pressure) is unique because it helps keep the airways open in premature infants by maintaining a small amount of pressure in the lungs at the end of exhalation, which can improve breathing and gas exchange. Unlike other treatments, PEEP is specifically adjusted to prevent airway collapse and is used immediately after birth to support infants with underdeveloped lungs.
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