PEEP Levels for Premature Birth
(POLAR Trial)
Recruiting in Palo Alto (17 mi)
+31 other locations
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Murdoch Childrens Research Institute
Disqualifiers: Severe pulmonary hypoplasia, Major congenital anomaly, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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.
12345Is 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.
12567How 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.
12589Eligibility Criteria
The POLAR trial is for very premature infants born between 23 and 28 weeks who need help breathing at birth. It's not for babies with severe lung problems, major birth defects, or those whose families decide against aggressive care.Inclusion Criteria
My newborn needed breathing support right after birth due to being premature.
My baby was born between 23 and 28 weeks of pregnancy.
Exclusion Criteria
My baby is expected to have severe lung issues due to early water break or fluid buildup.
My legal representative has not agreed to the clinical trial.
I have a major birth defect or another reason for my breathing problems.
Participant Groups
This study tests two ways of using PEEP in resuscitation: a constant level versus starting high then lowering it. The goal is to see which method better prevents lung collapse without increasing the risk of chronic lung disease.
2Treatment groups
Experimental Treatment
Active Control
Group I: Dynamic PEEP GroupExperimental Treatment1 Intervention
Dynamic delivery of PEEP at 8 cmH2O via a T-piece resuscitator using an initial fraction of inspired oxygen (FiO2) of 0.30 via local standard interface (facemask, nasopharyngeal tube or nasal prong). PEEP levels increased step-wise to 10 and/or 12 cmH2O if FiO2/respiratory care needs to be escalated as per a standardised resuscitation algorithm.
If an infant shows evidence of respiratory improvement during resuscitative care, PEEP will be reduced in a stepwise method by 2 cmH2O each reduction, but to no lower than 8 cmH2O.
Group II: Static PEEP GroupActive Control1 Intervention
Delivery of PEEP at 5-6 cmH2O via a T-piece resuscitator using an initial fraction of inspired oxygen (FiO2) of 0.30 via local standard interface (facemask, nasopharyngeal tube or nasal prong). FiO2 and other aspects of respiratory care are then titrated using a standardised resuscitation algorithm.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Rady Children's at Scripps Memorial Hospital La Jolla/UCSDSan Diego, CA
Rady Children's at Rancho Springs Medical Center/UCSDSan Diego, CA
Indiana University / Riley Children Health at Indiana University HealthIndianapolis, IN
University of Arkansas for Medical SciencesLittle Rock, AR
More Trial Locations
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Who is running the clinical trial?
Murdoch Childrens Research InstituteLead Sponsor
University of PennsylvaniaCollaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Collaborator
University of OxfordCollaborator
References
A novel approach using volumetric dynamic airway computed tomography to determine positive end-expiratory pressure (PEEP) settings to maintain airway patency in ventilated infants with bronchopulmonary dysplasia. [2020]Positive end-expiratory pressure (PEEP) is a key mechanical ventilator setting in infants with bronchopulmonary dysplasia (BPD). Excessive PEEP can result in insufficient carbon dioxide elimination and lung damage, while insufficient PEEP can result in impaired gas exchange secondary to airway and alveolar collapse. Determining PEEP settings based on clinical parameters alone is challenging and variable.
Differential Prognostic Analysis of Higher and Lower PEEP in ARDS Patients: Systematic Review and Meta-Analysis. [2023]Positive end-expiratory pressure (PEEP) refers to the positive pressure in the respiratory tract at the end of the exhalation when we use a ventilator. The differences of higher PEEP and lower PEEP on clinical outcomes in acute respiratory distress syndrome (ARDS) patients are less well known.
Effects of varying levels of positive end-expiratory pressure on intracranial pressure and cerebral perfusion pressure. [2022]To determine the influence of positive end-expiratory pressure (PEEP) on intracranial pressure and cerebral perfusion pressure.
Application of two different nasal CPAP levels for the treatment of respiratory distress syndrome in preterm infants-"The OPTTIMMAL-Trial"-Optimizing PEEP To The IMMAture Lungs: study protocol of a randomized controlled trial. [2021]Nasal continuous positive airway pressure (CPAP) applies positive end-expiratory pressure (PEEP) and has been shown to reduce the need for intubation and invasive mechanical ventilation in very low birth weight infants with respiratory distress syndrome. However, CPAP failure rates of 50% are reported in large randomized controlled trials. A possible explanation for these failure rates is the application of insufficient low levels of PEEP during nasal CPAP treatment to maintain adequate functional residual capacity shortly after birth. The optimum PEEP level to treat symptoms of respiratory distress in very low birth weight infants has not been assessed in clinical studies. The aim of the study is to compare two different PEEP levels during nasal CPAP treatment in preterm infants.
Variation in Positive End-Expiratory Pressure Levels for Mechanically Ventilated Extremely Low Birth Weight Infants. [2019]To test the hypothesis that significant positive end-expiratory pressure (PEEP) level variation exists between neonatal centers.
Positive end-expiratory pressure during mechanical ventilation and noninvasive respiratory support in newborns and children. [2019]Positive end-expiratory pressure (PEEP) is used during non-invasive and invasive ventilation of newborns, infants and children. PEEP improves gas exchange by increasing the functional residual capacity, reduces the respiratory effort, lowers requirements for respiratory mixture oxygen, and enables to decrease the peak inspiratory pressure (PIP) without decreasing the mean airway pressure. Its effects on the cardiovascular system appear to be insignificant, particularly in patients with severe respiratory failure that is not accompanied by circulatory insufficiency. The value of PEEP enabling to provide the optimal conditions for improvement of gas exchange should be tailored individually for each patient under control of blood gas analysis, PIP and FiO₂. This strategy minimises ventilator-induced lung injury and prevents the development of circulatory failure associated with ventilation. Nasal continuous positive airway pressure (NCPAP) used with various PEEP values is a recognised treatment method of respiratory failure in newborns, especially in preterm infants.
PEEP and CPAP. [2022]Positive end-expiratory pressure (PEEP) maintains airway pressure above atmospheric at the end of expiration, and may be used with mechanical ventilation or spontaneous breathing. CPAP, or continuous positive airway pressure, refers to spontaneous ventilation with a positive airway pressure being maintained throughout the whole respiratory cycle. PEEP/CPAP primarily improves oxygenation by increasing functional residual capacity, and may increase lung compliance and decrease the work of breathing. PEEP/CPAP may be applied using endotracheal tubes, nasal masks or prongs, or face masks or chambers to treat a wide range of adult and paediatric respiratory disorders. Complications associated with their use relate to the pressures applied and include pulmonary barotrauma, decreased cardiac output and raised intracranial pressure.
Positive end-expiratory pressure during resuscitation at birth in very-low birth weight infants: A randomized-controlled pilot trial. [2019]There is limited evidence of the effect of positive end-expiratory pressure (PEEP) during resuscitation soon after birth. Premature neonates may experience respiratory distress from surfactant insufficiency and providing PEEP after the very first breath, may improve outcomes following appropriate resuscitation. The objective of this study was to evaluate the short term respiratory outcomes after positive pressure ventilation (PPV) with PEEP in preterm infants at birth.
Neonatal ventilation with a manikin model and two novel PEEP valves without an external gas source. [2017]Positive end expiratory pressure (PEEP) is beneficial when ventilating preterm newborns. The aim was to study whether inexperienced providers were able to generate PEEP during simulated neonatal ventilation, using two novel prototype PEEP valves, on a self-inflating bag without an external gas source.