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Respiratory Stimulant

Doxapram for Respiratory Insufficiency

Phase 3

Recruiting

Led By Anne Smits, MD, PhD

Research Sponsored by Erasmus Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years corrected age

Awards & highlights

Study Summary

This trial is looking at the use of a medication called doxapram to help preterm infants who suffer from breathing problems known as apnea of prematurity (AOP). AOP can lead

Who is the study for?

The DOXA trial is for preterm infants born before 29 weeks who are in the NICU and still have breathing pauses despite caffeine treatment and non-invasive respiratory support. Parents must consent to participate. Infants not eligible include those with certain conditions that make them unsuitable for the study.Check my eligibility

What is being tested?

This study tests whether Doxapram, a drug that stimulates breathing, can help prevent severe apnea (breathing stops) and reduce the need for invasive mechanical ventilation which could lead to lung disease or poor brain development compared to a placebo.See study design

What are the potential side effects?

Doxapram may cause side effects such as increased heart rate, blood pressure changes, irritability, jitteriness, gastrointestinal disturbances like vomiting or diarrhea, seizures in rare cases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Death or severe disability

Secondary outcome measures

Additional long term outcomes

Admission period

Broncho pulmonary dysplasia

+9 more

Side effects data

From 2008 Phase 2 trial • 49 Patients • NCT00477451

45%

SEDATION

20%

Dysgeusia

COUGH

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

RCT Alprazolam 1 mg

Initial Inhaled Alprazolam 2 mg

RCT Placebo

Open Label Inhaled Alprazolam 1 mg

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DoxapramExperimental Treatment1 Intervention

Blinded doxapram (2mg/ml, in glucose 5%) loading dose of 2.0 to 2.5 mg/kg administered in 5 to 10 minutes, followed by a continuous infusion of 0.5 - 1.0 mg/kg/hr ('www.kinderformularium.nl') as long as needed. Therapy is down titrated or stopped based on the patients' respiratory condition. If endotracheal intubation is needed study drug is stopped. After extubation study drug may be restarted. Switch to gastro-enteral administration is allowed if no iv-access is needed for other reasons.

Group II: PlaceboPlacebo Group1 Intervention

Placebo (glucose 5%) will also be administered with a loading dose and continuous infusion (in equal amounts of fluid as in experimental arm) by intravenous or gastro-intestinal infusion. The treatment protocol will be equal to the protocol in the doxapram arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxapram

2016

Completed Phase 4

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Universitaire Ziekenhuizen LeuvenOTHER

849 Previous Clinical Trials

1,238,974 Total Patients Enrolled

Nederlands Neonataal Netwerk (N3), the NetherlandsUNKNOWN

Erasmus Medical CenterLead Sponsor

649 Previous Clinical Trials

1,877,307 Total Patients Enrolled

3 Trials studying Respiratory Insufficiency

386 Patients Enrolled for Respiratory Insufficiency

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively seeking participants for this study at the moment?

"As per details on clinicaltrials.gov, this investigation is presently open for enrollment. The trial's initial posting was on June 15th, 2020 and the most recent update occurred on March 15th, 2024."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"A total of 396 eligible individuals are sought to partake in this research endeavor. Potential participants have the option to engage in this clinical investigation at various locations, such as Maastricht University Medical Center situated in Maastricht, Limburg and Maxima Medical Center Veldhoven located in Veldhoven, Noord-Brabant."

Answered by AI

In how many medical facilities is this examination being conducted?

"At this time, patient recruitment for the trial is ongoing at 25 different sites. These include cities such as Maastricht, Veldhoven, and Zwolle among others. Opting for a nearby site can reduce travel burden when taking part in the study."

Answered by AI

What is the safety profile of Doxapram in clinical settings?

"Based on our team's evaluation at Power, the safety rating for Doxapram is designated as a 3 in this Phase 3 trial. This ranking signifies that there is existing evidence supporting its effectiveness and multiple datasets affirming its safety profile."

Answered by AI

Is this trial open to individuals under the age of 50?

"Individuals eligible for participation in this research study must be aged between 23 weeks and 29 weeks. Among the available studies, there are 22 focused on participants under 18 years old and 156 targeted towards those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Doxapram Therapy in Preterm Infants (DOXA Trial)

Sinno H.P. Simons 2020. "Doxapram Therapy in Preterm Infants (DOXA Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04430790.