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Study on Automatic Oxygen Control for Extremely Preterm Infants Using Oxygen PH.EUR.

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a new method for controlling the amount of oxygen given to extremely preterm infants, who are babies born very early, between 23 and 27 weeks of pregnancy. The treatment being tested is called OXYGEN PH.EUR., which is a type of oxygen used in medical settings. The study aims to compare a new automatic system that adjusts the oxygen levels with the traditional manual method used by healthcare providers. This is important because the right amount of oxygen is crucial for the health and development of these infants.

The purpose of the study is to see if the automatic system can improve outcomes for these infants, such as reducing the risk of complications like retinopathy of prematurity (a serious eye condition), chronic lung disease, and necrotizing enterocolitis (a severe intestinal disease). The study will also look at the overall survival and development of the infants up to 24 months after their expected due date. The trial will involve monitoring the infants closely to see if the automatic system provides better results than the manual method.

Throughout the study, infants will receive oxygen through standard infant ventilators, which are machines that help them breathe. The trial will last until the infants are discharged from the hospital, and their development will be assessed at 24 months. This research is important to potentially improve the care and outcomes for extremely preterm infants by ensuring they receive the right amount of oxygen in a safe and effective way.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study involves infants born between 23 weeks and 27 weeks and 6 days of gestation. Participation begins after birth, once eligibility is confirmed.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline health information. This includes evaluating the infant's current respiratory support needs.

  3. Step 3

    Randomization

    Infants are randomly assigned to one of two groups: one receiving closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) and the other receiving manual adjustments of the inspired oxygen fraction (FiO2).

  4. Step 4

    Treatment phase

    During the treatment phase, infants receive oxygen therapy through standard infant ventilators. The group with closed-loop control will have automatic adjustments to the oxygen levels, while the other group will have manual adjustments.

    The treatment continues throughout the infant's stay in the hospital, with regular monitoring to ensure safety and efficacy.

  5. Step 5

    Monitoring and follow-up

    Infants are monitored for any complications related to prematurity, such as severe retinopathy of prematurity, chronic lung disease, or necrotizing enterocolitis.

    Follow-up assessments are conducted until the infant is discharged from the hospital.

  6. Step 6

    Long-term follow-up

    At 24 months corrected age, a follow-up assessment is conducted to evaluate neurodevelopmental outcomes. This includes checking for motor disabilities, language or cognitive delays, and any severe visual or hearing impairments.

Who can join the trial?

3 criteria

  • The baby must have been born between **23 weeks and 0 days** and **27 weeks and 6 days** of pregnancy. This is known as the **gestational age**.
  • Both **male and female** babies can participate.
  • The study includes babies who are considered a **vulnerable population**, meaning they may need special care or protection.
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Investigated drugs

Closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) is a technology used in standard infant ventilators. It automatically adjusts the amount of oxygen that extremely preterm infants receive during mechanical ventilation or other forms of respiratory support. This system aims to maintain the right oxygen levels in the infant's blood without needing constant manual adjustments by healthcare providers. The trial is studying how well this automatic system works compared to the usual method where healthcare providers manually adjust the oxygen levels.

What is already known about the treatment

FiO2-C – This is a method used in the management of extremely preterm infants, specifically those born between 23 and 27 weeks of gestation. It involves the closed-loop automatic control of the inspiratory fraction of oxygen (FiO2) in standard infant ventilators. The current status of this method is under clinical trial to evaluate its safety and efficacy compared to manual adjustments of oxygen levels. The main therapeutic indication is to improve respiratory outcomes in preterm infants by optimizing oxygen delivery. The mechanism of action involves automatically adjusting the oxygen levels based on the infant's needs, reducing the risk of oxygen-related complications. This method falls under the pharmacological classification of respiratory support technologies.

Investigated diseases

  • Severe Retinopathy of Prematurity

    This is a condition that affects the eyes of premature infants, particularly those born before 31 weeks of gestation. It occurs when abnormal blood vessels grow in the retina, which can lead to scarring and retinal detachment. The disease progresses through several stages, with the early stages often showing no symptoms. As it advances, it can cause vision problems or even blindness if not monitored and managed. The condition is more likely to develop in infants with lower birth weights and those who require oxygen therapy.

  • Chronic Lung Disease of Prematurity

    Also known as bronchopulmonary dysplasia, this condition affects the lungs of premature infants who have received oxygen therapy or mechanical ventilation. It is characterized by inflammation and scarring in the lungs, which can lead to breathing difficulties. The disease develops over time, often starting with respiratory distress shortly after birth. As the infant grows, the lungs may improve, but some children may continue to experience respiratory issues. The severity can vary, with some infants requiring prolonged respiratory support.

  • Necrotizing Enterocolitis

    This is a serious gastrointestinal condition that primarily affects premature infants. It involves inflammation and bacterial invasion of the intestine, which can lead to tissue death. The disease typically presents with feeding intolerance, abdominal distension, and bloody stools. It can progress rapidly, potentially leading to perforation of the intestine. The exact cause is not fully understood, but it is believed to be related to an immature immune system and gut flora imbalance. Early detection and management are crucial to prevent complications.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-511335-10-01Protocol codeFiO2-CEstimated enrolment1 082 patientsSponsorUniversitaetsklinikum Tuebingen AöR

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