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Study on the Effects of 30% vs. 60% Oxygen Levels at Birth for Improving Development in Premature Infants

Registered 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 different oxygen levels on the development of very low birthweight infants who are born prematurely. Premature birth, or prematurity, occurs when a baby is born before 37 weeks of pregnancy. The study will use Medical Oxygen, which is a type of oxygen used in medical settings, to see if starting with a higher concentration of 60% oxygen compared to a lower concentration of 30% oxygen at birth can improve the infants' development by the time they reach 18 to 24 months of age.

The purpose of the study is to determine if there is any difference in the rate of survival or developmental outcomes between the two oxygen levels. The study will follow the infants from birth until they are 18 to 24 months old. During this time, researchers will monitor the infants for any major developmental issues, such as difficulties with movement, severe learning delays, hearing problems that require aids, or significant vision problems.

In addition to the main outcomes, the study will also look at other health issues that might occur in the hospital, such as severe brain injuries, a lung condition called bronchopulmonary dysplasia, and a serious eye condition known as retinopathy of prematurity. The study aims to provide valuable information on how different oxygen levels at birth can affect the health and development of premature infants.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Infants with a gestational age between 23 to 28 weeks are eligible to participate in the study. The decision to join the study is based on the best available obstetrical estimate.
Infants must be designated to receive full resuscitation, meaning there is no parental request or pre-determined decision to forego resuscitation.
Infants with no known major congenital or chromosomal malformations are considered for participation.
Step 2
Initial treatment
The study involves the administration of Medical Oxygen as a medicinal gas, compressed through inhalation.
Two different concentrations of oxygen are used: 30% and 60%.
The objective is to determine if a higher concentration of 60% oxygen improves neurodevelopmental outcomes compared to a lower concentration of 30%.
Step 3
Monitoring and follow-up
The primary outcome is assessed between 18 and 24 months of corrected age. This includes evaluating all-cause mortality or the presence of major neurodevelopmental outcomes.
Major neurodevelopmental outcomes are defined as non-ambulatory cerebral palsy, severe cognitive delay, hearing impairment requiring aids or implants, and significant visual impairment.
Step 4
Secondary outcomes
Secondary outcomes include all-cause in-hospital mortality, severe brain injury, bronchopulmonary dysplasia, and severe retinopathy of prematurity.
Severe brain injury is identified through specific types of hemorrhages or lesions detected via cranial ultrasound.
Step 5
Trial duration
The estimated end date for the trial is December 30, 2027.
Recruitment for the study is expected to start on February 1, 2024.

Who can join the trial?

3 criteria

Infants with a **gestational age** between 23 to 28 weeks. Gestational age is the age of the baby calculated from the mother's last menstrual period.
Infants who are planned to receive full **resuscitation**. Resuscitation means medical help to support breathing and heart function. There should be no parental request or decision made beforehand to not provide this help.
No known major **congenital** or **chromosomal malformation**. This means the infant should not have any significant birth defects or genetic disorders known before birth.

Who cannot join the trial?

1 criterion

Infants born before the normal full-term pregnancy period, known as prematurity, cannot participate.

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Investigated drugs

Oxygen Therapy In this clinical trial, oxygen therapy is used to resuscitate very low birthweight infants who are born prematurely, between 23 to 28 weeks of gestation. The study is comparing the effects of using a higher oxygen concentration of 60% versus a lower concentration of 30% during the initial resuscitation process. The goal is to determine if the different oxygen levels have an impact on the infants' neurodevelopmental outcomes at 18-24 months of age.

Oxygen Ph.eur.

What is already known about the treatment

Oxygen Therapy – Oxygen therapy is administered through inhalation, typically using a mask or nasal cannula, to provide supplemental oxygen to patients. In medical literature, oxygen therapy is well-established and widely used, particularly in neonatal care. The main therapeutic indication for this trial is to assess its impact on neurodevelopmental outcomes in very low birthweight infants born prematurely. At the molecular level, oxygen therapy works by increasing the amount of oxygen available in the bloodstream, which is crucial for cellular metabolism and energy production. It is classified as a respiratory therapy, essential for supporting patients with compromised breathing or oxygenation.

Investigated diseases

Prematurity – Prematurity refers to a birth that occurs before the 37th week of pregnancy. Babies born prematurely may face various health challenges due to underdeveloped organs. Common issues include difficulty breathing, maintaining body temperature, and feeding. As they grow, premature infants may experience developmental delays and are at risk for conditions such as cerebral palsy and vision or hearing impairments. The degree of prematurity often influences the severity of these complications. Early medical intervention and supportive care are crucial for managing the health of premature infants.