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Study on the Effect of Caffeine Citrate for Patients with Extubation Failure and Bronchopulmonary Dysplasia

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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 an additional dose of caffeine citrate in preterm newborns who are at risk of extubation failure and bronchopulmonary dysplasia. Extubation failure occurs when a baby has difficulty breathing on their own after being taken off a breathing machine, while bronchopulmonary dysplasia is a lung condition that can affect premature infants. The treatment being tested is a solution of caffeine citrate, which is given through an injection to help stimulate breathing.

The purpose of the study is to see if giving an extra dose of caffeine citrate before removing the breathing tube can improve the chances of successful extubation. The study will monitor the need for reintubation, which means putting the breathing tube back in if the baby struggles to breathe on their own. It will also look at other factors like the frequency of breathing pauses (apneas), side effects such as increased heart rate or blood pressure, and any digestive issues. Additionally, the study will observe the development of conditions like necrotizing enterocolitis, a serious intestinal disease, and the progression of brain-related issues such as intraventricular hemorrhage or periventricular leukomalacia.

The trial will follow the participants over a period to assess their neurodevelopmental outcome, which refers to how well their brain develops and functions over time. The study aims to provide valuable insights into whether this additional caffeine citrate dose can help improve breathing outcomes and overall health in these vulnerable infants.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Eligibility is determined for preterm neonates born before the 32nd week of gestation who have been mechanically ventilated for at least 48 hours.
The assessment occurs before the first planned removal of the breathing tube (extubation).
Step 2
Administration of medication
An additional loading dose of caffeine citrate is administered.
The medication is given through an intravenous (IV) injection or infusion.
The purpose is to evaluate if this dose affects the success rate of extubation.
Step 3
Monitoring and observation
The primary focus is on whether reintubation is necessary.
Secondary observations include the frequency of breathing pauses (apnoeas), side effects such as elevated heart rate and blood pressure, and any gastric issues.
Other conditions monitored include necrotizing enterocolitis, bronchopulmonary dysplasia, and any progression of brain-related conditions like intraventricular hemorrhage or periventricular leukomalacia.
Neurodevelopmental outcomes are also assessed.
Step 4
Completion of trial
The trial is estimated to conclude by April 4, 2027.
The results will contribute to understanding the impact of the additional caffeine citrate dose on extubation success.

Who can join the trial?

6 criteria

The study is for **preterm neonates**, which means babies born earlier than expected.
The babies must be born **before the 32nd week of gestation**. Gestation is the period a baby is in the mother's womb.
The babies must have been on a **mechanical ventilator** for at least 48 hours. A mechanical ventilator is a machine that helps babies breathe.
The study is for babies who are about to have their **first planned extubation**. Extubation is the process of removing the breathing tube.
Both **male and female** babies can participate in the study.
The study includes babies who are considered a **vulnerable population**, meaning they need special protection and care.

Who cannot join the trial?

5 criteria

Patients who have not experienced extubation failure or do not have bronchopulmonary dysplasia cannot participate. Extubation failure means that a patient has difficulty breathing on their own after a breathing tube is removed. Bronchopulmonary dysplasia is a lung condition that affects newborns, especially those who were born prematurely.
Patients who are not within the specified age range for the study cannot participate. The study is focused on a specific age group.
Patients who do not belong to the specified clinical trial group cannot participate. The study is designed for a particular group of patients.
Patients who are not male or female cannot participate. The study includes both male and female participants.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Verified
Gyor, Hungary
Semmelweis University
Responsive
Budapest, Hungary
University Of Debrecen
Verified
Debrecen, Hungary

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Investigated drugs

Caffeine-Citrate is a medication used in this clinical trial to see if giving an extra dose before removing a breathing tube can help improve the chances of successfully taking the tube out. Caffeine-Citrate is often used to stimulate breathing in premature babies, and this study is exploring if an additional dose can make a difference in the extubation process.

Caffeine Citrate

What is already known about the treatment

Caffeine Citrate – Caffeine Citrate is administered orally or intravenously and is currently being studied for its effects on extubation success in newborns with extubation failure and bronchopulmonary dysplasia. It is well-documented in medical literature as a treatment for apnea of prematurity. The main therapeutic indication in this trial is to improve the success rate of extubation in infants. At the molecular level, Caffeine Citrate works by stimulating the central nervous system and respiratory system, enhancing breathing efforts. It is classified pharmacologically as a central nervous system stimulant.

Investigated diseases

Extubation Failure
This condition occurs when a patient is unable to maintain adequate breathing after the removal of a breathing tube. It often requires reintubation, where the tube is reinserted to assist with breathing. The failure can be due to various factors, including muscle weakness or airway obstruction. It is commonly observed in patients who have been on mechanical ventilation for extended periods. Monitoring and supportive care are crucial to manage this condition effectively.
Bronchopulmonary Dysplasia
This is a chronic lung condition that primarily affects premature infants who have received oxygen therapy or mechanical ventilation. It involves inflammation and scarring in the lungs, leading to breathing difficulties. The condition can result in long-term respiratory problems and requires careful management. Infants with this condition may experience rapid breathing, wheezing, and difficulty feeding. Over time, the lungs may develop more normally, but some children may continue to have respiratory issues.