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Study on Doxapram for Treating Apnea in Preterm Newborns

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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 a condition known as apnea of prematurity, which affects newborns who are born too early, also known as preterm infants. The trial is investigating a treatment using a medication called doxapram, which is given as a solution through an intravenous infusion. The purpose of the study is to determine if doxapram is safe and effective in reducing the risk of death and severe developmental problems in these infants when compared to a placebo.

During the study, preterm newborns will receive either doxapram or a placebo. The treatment will be administered over a period of time, and the infants will be monitored closely by healthcare professionals. The study aims to observe the effects of the treatment on the infants' health and development up to the age of 18 to 24 months.

The trial is designed to provide valuable information on whether doxapram can help improve outcomes for preterm infants with apnea of prematurity. By comparing the results between those receiving doxapram and those receiving a placebo, researchers hope to gain insights into the potential benefits and safety of this treatment for vulnerable newborns.

The research process

The trial runs in 5 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 preterm newborns with a gestational age at birth of less than 29 weeks.

    The newborn must be admitted to the Neonatal Intensive Care Unit (NICU) of a participating center.

    Written informed consent is required from the parent(s) or legal representatives according to national guidelines.

  2. Step 2

    Eligibility confirmation

    The newborn must be at least 120 hours old postnatally.

    The newborn should be receiving caffeine therapy at an adequate dose.

    Optimal non-invasive respiratory support should be provided according to local treatment policy, which may include nasal CPAP or ventilation methods such as (S)NIPPV, BIPAP/Duopap, or nasal HFO.

    The newborn must experience frequent and/or severe apneas that require medical intervention as judged by the attending physician.

  3. Step 3

    Treatment administration

    The trial involves the administration of doxapram hydrochloride monohydrate or a placebo.

    The medication is given intravenously as a solution for infusion.

    The specific dosage and frequency of administration are determined by the study protocol and the attending medical team.

  4. Step 4

    Monitoring and follow-up

    The primary outcome of the trial is to assess the composite outcome of death or severe disability at the age of 18-24 months corrected age.

    Both outcomes will also be analyzed separately to determine the safety and effectiveness of doxapram compared to placebo.

  5. Step 5

    Trial completion

    The estimated end date for the trial is April 1, 2027.

    The results will contribute to understanding the safety and effectiveness of doxapram in reducing severe outcomes in preterm newborns.

Who can join the trial?

7 criteria

  • Admitted to the NICU (Neonatal Intensive Care Unit) of one of the participating centers
  • Written informed consent according to the national guidelines of both (the Netherlands) or at least one (Belgium and Canada) parent(s) or legal representatives
  • Born with a **gestational age** of less than 29 weeks (gestational age is the time period from the first day of the mother's last menstrual cycle to the current date, measured in weeks)
  • At least 120 hours old after birth
  • Receiving **caffeine therapy** with the correct dosage (caffeine therapy is a treatment used to help stimulate breathing in premature babies)
  • Receiving the best possible non-invasive breathing support according to local treatment policy, which may include nasal CPAP or ventilation methods like (S)NIPPV, BIPAP/Duopap, or nasal HFO (these are different types of breathing support that help babies breathe without needing a tube in their windpipe)
  • Experiencing frequent and/or severe **apneas** that need medical intervention as decided by the attending doctor (apnea is a condition where breathing stops for a short period)

Who cannot join the trial?

9 criteria

  • Patients who have a known allergy or adverse reaction to the study medication.
  • Patients with a medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of a serious heart condition.
  • Patients who have a history of severe liver or kidney disease.
  • Patients who are unable to follow the study procedures as required.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a condition that affects their ability to understand the study and provide consent.
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Investigated drugs

Doxapram is a medication being studied to see if it is safe and effective for use in preterm newborns. The trial aims to determine if it can help reduce the risk of death and neurodevelopmental problems or severe disabilities in these infants when they reach 18 to 24 months of corrected age.

What is already known about the treatment

Doxapram – Doxapram is administered intravenously and is currently being studied in clinical trials for its effectiveness and safety in treating apnea of prematurity in preterm newborns. It is not yet widely established in medical practice for this use, as research is ongoing to determine its long-term effects and benefits. The medication works by stimulating the respiratory center in the brain, which helps increase breathing rate and depth. Doxapram is classified as a respiratory stimulant, and its primary therapeutic indication in this trial is to reduce the risk of death and severe neurodevelopmental impairment in affected infants.

Investigated diseases

Apnea of Prematurity – This condition occurs in premature infants and is characterized by pauses in breathing for more than 20 seconds. These pauses can be accompanied by a decrease in heart rate and a drop in blood oxygen levels. It is primarily due to the immaturity of the respiratory control centers in the brain. The condition is most common in infants born before 34 weeks of gestation. As the infant matures, the frequency and severity of apnea episodes typically decrease. Most infants outgrow this condition as their respiratory system develops.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-515625-29-00Protocol codeNL72125.078.19Estimated enrolment396 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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