Ongoing Clinical Trials for Infantile Apnoea
There are currently 3 ongoing clinical trials studying treatments for infantile apnoea, a breathing condition that affects preterm newborns. These trials are testing different approaches including respiratory stimulants and automatic oxygen control systems, and are being conducted across Belgium, Germany, Hungary, and the Netherlands.
Clinical trial locations
- Belgium
- Germany
- Hungary
- Netherlands
Study on Doxapram for Treating Apnea in Preterm Newborns
This trial is investigating doxapram, a respiratory stimulant medication, for treating apnea of prematurity in very premature newborns. The condition occurs when breathing stops temporarily, which is particularly common in babies born before 29 weeks of pregnancy.
Main inclusion criteria: The study includes preterm infants born at less than 29 weeks gestational age who are admitted to a Neonatal Intensive Care Unit. To participate, babies must be at least 120 hours old, already receiving caffeine therapy at the correct dosage, and using optimal non-invasive breathing support such as nasal CPAP or similar ventilation methods. Most importantly, infants must be experiencing frequent or severe breathing pauses that require medical intervention despite these existing treatments.
Main exclusion criteria: Babies cannot participate if they have a known allergy to the study medication, have medical conditions that would make participation unsafe, are already enrolled in another clinical trial, or have serious heart, liver, or kidney disease. Infants whose parents or guardians cannot follow the study procedures are also excluded.
Focus and goals: The primary goal is to determine whether doxapram is safe and effective in reducing the combined risk of death and severe developmental disabilities by the time infants reach 18 to 24 months of corrected age. The medication is given through an intravenous infusion and compared against a placebo. Healthcare professionals will closely monitor the infants throughout the treatment period and assess their health and development over time.
Investigational drug: Doxapram hydrochloride monohydrate is administered as an intravenous solution. It works by stimulating the respiratory control centers in the brain, helping to increase breathing rate and depth in premature infants experiencing apnea.
Study on the Effect of Caffeine Citrate for Patients with Extubation Failure and Bronchopulmonary Dysplasia
This trial examines whether giving an additional loading dose of caffeine citrate before removing a breathing tube can improve success rates in preterm newborns at risk of breathing difficulties and lung disease.
Main inclusion criteria: The study enrolls preterm babies born before 32 weeks of gestation who have been on a mechanical ventilator for at least 48 hours. Both male and female infants can participate, and eligibility is assessed before their first planned extubation, which is the process of removing the breathing tube.
Main exclusion criteria: Infants who have not experienced extubation failure or do not have bronchopulmonary dysplasia cannot participate. The study is designed for a specific age range and clinical group, and patients outside these parameters are excluded.
Focus and goals: The main focus is determining whether the extra caffeine dose reduces the need for reintubation, meaning putting the breathing tube back in if the baby struggles to breathe independently. The study also monitors the frequency of breathing pauses, side effects such as elevated heart rate or blood pressure, digestive issues, and the development of serious conditions like necrotizing enterocolitis. Long-term neurodevelopmental outcomes are also assessed to understand how brain development progresses over time.
Investigational drug: Caffeine citrate is given through an intravenous injection or infusion. It is a central nervous system stimulant that is already used to treat apnea of prematurity, and this study explores whether an additional dose specifically helps with the extubation process.
Study on Automatic Oxygen Control for Extremely Preterm Infants Using Oxygen PH.EUR.
This trial compares a new automatic system for controlling oxygen levels in extremely premature infants with the traditional manual method used by healthcare providers. Proper oxygen management is critical for preventing complications in babies born very early.
Main inclusion criteria: The study includes extremely preterm infants born between 23 weeks and 27 weeks and 6 days of gestation. Both male and female babies can participate. These infants are considered a vulnerable population requiring special care.
Main exclusion criteria: Specific exclusion criteria are determined based on the infant’s health status and ability to safely participate in the study, though detailed exclusions were not specified in the provided information.
Focus and goals: The trial aims to determine whether closed-loop automatic control of oxygen levels can improve outcomes compared to manual adjustments. Infants are randomly assigned to receive either automatic or manual oxygen control through standard infant ventilators. Researchers will monitor for complications such as severe retinopathy of prematurity, chronic lung disease, and necrotizing enterocolitis. The study also tracks overall survival and conducts follow-up assessments at 24 months of corrected age to evaluate neurodevelopmental outcomes, including motor skills, language and cognitive development, and any vision or hearing impairments.
Investigational approach: The closed-loop automatic control system, known as FiO2-C, automatically adjusts the fraction of inspired oxygen based on the infant’s needs without requiring constant manual intervention by healthcare providers. This technology is integrated into standard infant ventilators and aims to maintain optimal oxygen levels in the infant’s blood, reducing the risk of oxygen-related complications.
Summary
The three ongoing clinical trials for infantile apnoea represent diverse approaches to managing breathing difficulties in premature newborns. Two trials focus on respiratory stimulant medications—doxapram and caffeine citrate—while one examines an innovative automatic oxygen control system. Geographically, the trials are distributed across Western and Central Europe, with Belgium and the Netherlands collaborating on the doxapram study, Hungary conducting the caffeine citrate research, and Germany investigating the automatic oxygen control technology.
A notable pattern is that all three trials target extremely vulnerable populations: very premature infants born before 29-32 weeks of gestation. The studies address different aspects of respiratory support, from preventing apnea episodes to improving extubation success and optimizing oxygen delivery. The longest follow-up period extends to 24 months of corrected age, reflecting the importance of understanding not just immediate respiratory outcomes but also long-term neurodevelopmental effects. All three trials are expected to conclude around 2027, which will provide valuable comparative data on different treatment approaches for this critical condition.
