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Testing Caffeine Citrate for Reducing Breathing Support Needs in Premature Newborns with Primary Apnea

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What is this trial about?

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

This study involves primary apnea in preterm newborns, which is a condition where very premature babies experience pauses in breathing. The treatment being studied is Peyona, which contains caffeine citrate as its active ingredient. This medication is given to help premature babies breathe more regularly and reduce episodes when they stop breathing. The study will examine how this medication works in babies born extremely early, between 24 and 28 weeks of pregnancy, and those born very early, between 28 and 33 weeks of pregnancy.

The purpose of the study is to measure the levels of caffeine in saliva samples from premature babies receiving this treatment and to see how these levels relate to how long the babies need breathing support with machines. During the study, saliva samples will be collected from the babies at different times to measure caffeine levels. Researchers will observe how well the babies respond to the treatment by tracking how long they need help with breathing machines, how often they have episodes where they stop breathing, and when they can safely stop taking the caffeine medication. The study will also look at whether caffeine levels affect pain scores and vital signs like heart rate and blood pressure.

The study will monitor various health outcomes in these premature babies, including complications that can occur in very early babies such as lung problems, eye problems, heart problems, and brain-related issues. Researchers will also track any side effects that may be related to the caffeine treatment, such as fast heart rate, seizures, irritability, feeding problems, or changes in urine output. Additionally, the study will examine how the babies' bodies process caffeine by measuring both caffeine and a substance called paraxanthine in their saliva, which helps understand how quickly each baby breaks down the medication.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Starting treatment with caffeine citrate

    On the first day of the study, called Day 0, treatment with caffeine citrate will begin. The medication is also known by the brand name Peyona.

    The medication will be given either through an intravenous access port (a small tube inserted into a vein) or by mouth, depending on the medical condition.

    The attending doctor will determine the exact dosage and frequency of administration based on individual medical needs.

    This medication is used to treat primary apnea, which means pauses in breathing that can occur in premature newborns.

  2. Step 2

    Saliva sample collection

    Throughout the study period, saliva samples will be collected using a sterile gauze pad placed in the mouth.

    These samples are collected to measure the levels of caffeine and its breakdown product called paraxanthine in the body.

    The collection will occur at specific times during the treatment to track how the medication is working.

  3. Step 3

    Monitoring of breathing support

    The medical team will monitor the need for invasive respiratory support, which means breathing assistance provided through a tube.

    This monitoring will be performed on Day 11 of the study and again at 36 weeks of postmenstrual age (the time calculated from the first day of the last menstrual period before pregnancy).

    The duration and type of breathing support needed will be recorded throughout the study.

  4. Step 4

    Assessment of apnea episodes

    The frequency and severity of apnea episodes (pauses in breathing) will be monitored throughout the study.

    The medical team will count how many episodes occur per 24 hours.

    This information will help determine how well the caffeine treatment is working.

  5. Step 5

    Pain and comfort evaluation

    Pain and comfort levels will be assessed using a tool called the COMFORTneo Scale.

    Vital signs such as heart rate and blood pressure will be measured regularly.

    These measurements help the medical team understand how the body is responding to the treatment.

  6. Step 6

    Monitoring for side effects

    The medical team will watch for possible side effects related to caffeine treatment.

    These may include tachycardia (faster than normal heart rate), convulsions (seizures), brain injury, irritability, jitters, or shaking.

    Digestive system effects such as feeding intolerance (difficulty tolerating feedings) or necrotizing enterocolitis (a serious intestinal condition) will also be monitored.

    Changes in urine output (the amount of urine produced) will be observed as well.

  7. Step 7

    Monitoring for complications related to prematurity

    Throughout the study, the medical team will monitor for complications that can occur in premature newborns.

    These include BPD (bronchopulmonary dysplasia, a lung condition), ROP (retinopathy of prematurity, an eye condition), and PDA (patent ductus arteriosus, a heart condition).

    Brain-related conditions will also be monitored, including periventricular hemorrhage or intraventricular hemorrhage (bleeding in or around the brain), periventricular leukomalacia (damage to brain tissue), posthemorrhagic hydrocephalus (fluid buildup in the brain after bleeding), and neonatal seizures (seizures in newborns).

  8. Step 8

    Continuing caffeine treatment

    Caffeine treatment will continue for as long as the attending doctor determines it is medically necessary.

    The medical team will monitor when it is appropriate to stop the caffeine therapy based on the medical condition and response to treatment.

    The duration of treatment varies for each patient depending on individual needs.

  9. Step 9

    Final assessment at 36 weeks postmenstrual age

    A final assessment will be conducted when the baby reaches 36 weeks of postmenstrual age.

    This assessment will include evaluation of breathing support needs and overall response to treatment.

    This marks the completion of the main study period.

Who can join the trial?

5 criteria

  • The baby must be born very early, between 24 weeks and 0 days to 32 weeks and 6 days of pregnancy (gestational age means how many weeks the pregnancy lasted)
  • The doctor caring for the baby must decide that treatment with caffeine citrate (a medicine called Peyona) is needed
  • The baby must have an intravenous access port (a small tube placed in a vein to give medicines directly into the bloodstream) already in place or planned to be placed on the first day of the study because of the baby's health needs
  • The baby's health condition must allow collecting saliva using a clean gauze pad (a small piece of sterile cloth used to gently collect saliva from the baby's mouth)
  • One of the parents must sign a consent form agreeing to the baby's participation in the study

Who cannot join the trial?

10 criteria

  • Major birth defects - serious problems with how the baby's body formed before birth that affect important organs or body parts
  • Congenital infections - infections that the baby was born with, passed from the mother during pregnancy
  • Neurological disorders - problems with the brain, spinal cord, or nerves that affect how the body works
  • Cardiovascular malformations - heart problems or problems with blood vessels that the baby was born with
  • Babies who need surgery within the first 7 days after birth
  • Babies receiving medicines that affect the heart rhythm, called antiarrhythmic drugs
  • Babies with a condition called necrotizing enterocolitis - a serious intestinal problem where parts of the bowel become damaged
  • Babies with severe bleeding in the brain, known as grade 3 or 4 intraventricular hemorrhage
  • Babies who are not expected to survive
  • Babies whose parents or legal guardians do not give permission for participation in the study
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Investigated drugs

Caffeine is a medication commonly used to help premature babies with their breathing. In this study, caffeine is being given to preterm infants to see how well it works in reducing the time they need breathing support through a tube or machine. The researchers will measure the amount of caffeine in the babies' saliva to understand how the body processes this medication and whether it helps improve breathing outcomes.

What is already known about the treatment

Caffeine – Caffeine is a medication given to premature newborn babies to help them breathe on their own by preventing episodes where they temporarily stop breathing, a condition called apnea of prematurity. It is typically administered orally or through an intravenous line, and it works by stimulating the central nervous system, specifically by blocking certain receptors in the brain called adenosine receptors, which helps activate the breathing centers and keeps the respiratory muscles working properly. Caffeine belongs to a class of drugs called methylxanthines and is widely recognized as a standard treatment in neonatal intensive care units for reducing the need for breathing machines in premature infants. This medication has been extensively studied and is considered safe and effective for improving breathing function and reducing complications in preterm babies.

Investigated diseases

Apnea of Prematurity – Apnea of prematurity is a condition that occurs in premature newborns where breathing stops for periods of time. This happens because the part of the brain that controls breathing is not fully developed in babies born too early. Episodes typically involve pauses in breathing lasting 20 seconds or longer, often accompanied by a slow heart rate or low oxygen levels in the blood. The condition is common in infants born before 34 weeks of pregnancy, and becomes more frequent in babies born at earlier stages. As the baby's brain and nervous system mature over time, these breathing pauses usually decrease in frequency and severity. Most premature infants outgrow this condition by the time they reach their original due date or shortly after.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2025-523475-33-00Protocol codeCAPPUCINO-2025Estimated enrolment200 patientsSponsorMasarykova Univerzita

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