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Doxapram Hydrochloride Monohydrate

This article discusses a clinical trial investigating the use of Doxapram Hydrochloride Monohydrate in treating apnea of prematurity. The study aims to determine the safety and effectiveness of this drug compared to a placebo in reducing death and neurodevelopmental impairment in preterm newborns. This Phase III trial involves multiple centers and focuses on infants born before 29 weeks of gestation.

Table of Contents

What is Doxapram?

Doxapram Hydrochloride Monohydrate, also known simply as Doxapram, is a medication currently being studied for its potential use in treating breathing problems in premature babies[1]. It belongs to a class of drugs called respiratory stimulants, which means it helps to encourage breathing[1].

Medical Condition: Apnea of Prematurity

The main medical condition that Doxapram is being studied for is called apnea of prematurity[1]. This is a common problem in premature babies where they temporarily stop breathing for short periods. These pauses in breathing can be frequent or severe and may require medical intervention[1].

Current Clinical Trial

A large-scale clinical trial is currently underway to investigate the safety and effectiveness of Doxapram in treating apnea of prematurity[1]. This trial is known as a Phase III clinical trial, which means it’s in an advanced stage of testing. The study is described as an “international double-blinded multicenter randomized controlled trial”[1]. Let’s break down what this means:

  • International: The study is being conducted in multiple countries.
  • Double-blinded: Neither the patients (in this case, the babies’ parents) nor the doctors know who is receiving the real drug and who is receiving a placebo (a harmless substance with no medical effect).
  • Multicenter: The study is taking place at multiple hospitals or medical centers.
  • Randomized controlled: Participants are randomly assigned to either receive Doxapram or a placebo, which helps ensure the results are not biased.

The main goal of this trial is to see if Doxapram is safe and effective in reducing deaths and neurodevelopmental problems (issues with brain and nervous system development) in premature babies at 18 to 24 months of corrected age, compared to a placebo[1].

Eligibility Criteria

The trial has specific criteria for which babies can participate. Some key inclusion criteria are[1]:

  • Babies born before 29 weeks of pregnancy
  • At least 5 days old
  • Already receiving caffeine therapy (another treatment for apnea of prematurity)
  • Experiencing frequent or severe apneas that require medical intervention

Some reasons a baby might not be eligible include[1]:

  • Previous use of Doxapram
  • Certain genetic conditions or major birth defects
  • Being in palliative care (end-of-life care)

Drug Information

In this trial, Doxapram is being given as a solution for infusion, which means it’s administered directly into the bloodstream through a vein (intravenously)[1]. The maximum daily dose being tested is 48 mg per kilogram of body weight, with a maximum rate of 2 mg per kilogram per hour[1]. The treatment period can last up to 10 days[1].

Potential Benefits and Risks

While the full results of this study are not yet known, the researchers hope that Doxapram might help reduce the risk of death and severe disability in premature babies with apnea[1]. However, as with any medical treatment, there may be risks involved. The purpose of this clinical trial is to better understand both the potential benefits and any possible risks of using Doxapram in premature babies[1].

It’s important to note that this medication is still being studied and is not yet approved for general use in treating apnea of prematurity. The results of this trial will help doctors and researchers determine if Doxapram should be used more widely for this condition[1].

Aspect Details
Drug Name Doxapram Hydrochloride Monohydrate
Trial Phase Phase III
Medical Condition Apnea of prematurity
Main Objective Investigate safety and effectiveness in reducing death and neurodevelopmental impairment
Participant Age Preterm newborns (< 29 weeks gestational age)
Administration Method Intravenous infusion
Maximum Daily Dose 48 mg/kg
Treatment Duration Up to 10 days
Primary Outcome Measure Death or severe disability at 18-24 months corrected age

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to investigate if Doxapram is safe and effective in reducing death and neurodevelopmental impairment or severe disability at 18 to 24 months corrected age in preterm newborns, compared to a placebo.
  • Who can participate in this trial? Participants must be preterm newborns born before 29 weeks of gestation, admitted to the NICU of a participating center, at least 120 hours old, and experiencing frequent or severe apneas requiring medical intervention.
  • How is Doxapram administered in this trial? Doxapram is administered as a solution for infusion through an intravenous route. The maximum daily dose is 48 mg/kg, with a maximum total dose of 2 mg/kg/h for up to 10 days.
  • Are there any exclusion criteria for the trial? Yes, exclusion criteria include previous use of open-label Doxapram, use of theophylline, chromosomal defects, major congenital malformations affecting lung function or neurodevelopment, and patients receiving palliative care.
  • What is the primary outcome measured in this trial? The primary outcome is a composite of death or severe disability at 18-24 months corrected age. These outcomes will also be analyzed separately.

Ongoing Clinical Trials on Doxapram Hydrochloride Monohydrate

  • Study on Doxapram for Treating Apnea in Preterm Newborns

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Belgium The Netherlands

Glossary

  • Apnea of prematurity: A condition in preterm infants where they temporarily stop breathing for short periods.
  • NICU: Neonatal Intensive Care Unit, a specialized unit in hospitals that cares for premature or critically ill newborns.
  • Gestational age: The length of pregnancy from the first day of the last menstrual period to birth.
  • Corrected age: The age of a preterm baby based on their due date rather than their actual birth date.
  • Caffeine therapy: A treatment used to reduce apnea episodes in premature infants.
  • CPAP: Continuous Positive Airway Pressure, a type of respiratory support that helps keep the airways open.
  • Neurodevelopmental impairment: Problems with brain function that affect a child's learning, language, or behavior.
  • Placebo: A substance with no active medical benefits, used as a control in testing new drugs.
  • Double-blinded: A study design where neither the participants nor the researchers know who is receiving the actual treatment or placebo.
  • Randomized controlled trial: A type of study where participants are randomly assigned to different treatment groups to compare outcomes.

References

  1. http://clinicaltrials.eu/trial/study-on-doxapram-for-treating-apnea-in-preterm-newborns/