Trial · NCT04430790
Doxapram Therapy in Preterm Infants (DOXA Trial)
NCT04430790, Phase 3, Recruiting, Erasmus Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Doxapram Therapy in Preterm Infants (DOXA Trial). Trials, record NCT04430790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04430790
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Doxapram Therapy in Preterm Infants (DOXA Trial)
- NCT number
- NCT04430790
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 396 participants, estimated
- Lead sponsor
- Erasmus Medical Center
- Conditions
- Apnea of Prematurity, Respiratory Insufficiency
- Interventions
- Doxapram, Placebo
- First posted
- 2020-06-12
- Last updated
- 2024-04-04
- Other registries' IDs
- eudract:2019-003666-41
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Death or severe disability | 2 years corrected age | Disability will be defined as cognitive delay, cerebral palsy, severe hearing loss, or bilateral blindness. Cognitive delay will be defined as a Mental Development Index score of less than 85 on the Bayley Scales of Infant and Toddler Development, Bayley Score of Infant Development (BSID) III scores. Cerebral palsy will be diagnosed if the child had a non-progressive motor impairment characterized by abnormal muscle tone and decreased range or control of movements. The level of gross motor function will be determined with the use of the Gross Motor Function Classification System. Audiometry will be performed to determine the presence or absence of hearing loss. Blindness will be defined as a corrected visual acuity less than 20/200 |
| Secondary | Broncho pulmonary dysplasia | 36 weeks post menstrual age | Diagnosed according to the National Institute of Child Health and Human Development (NICHD) criteria |
| Secondary | Death | until 36 weeks post menstrual age and until hospital discharge | Death at 36 weeks post menstrual age and hospital mortality |
| Secondary | Admission period | through study completion and until discharge home, average 3 months | Length of stay at the intensive care, length of stay in hospital |
| Secondary | Endotracheal intubations | Day 3, 7, 14, and 21 after start of study medication | Incidence of endotracheal intubations |
| Secondary | Oxygenation days and complications | During first hospital admittance and through study completion, average of 3 months | Number of days on invasive ventilation, number of days on ventilatory support (non-invasive ventilation, CPAP, humidified high flow, low flow), number of days with supplemental oxygen, respiratory complications (airleak, pneumonia, etc), use of (rescue) corticosteroids for respiratory reasons. |
| Secondary | Gastro-intestinal outcome measures | During first hospital admittance and until 36 weeks post menstrual age | solitary intestinal perforation, necrotizing enterocolitis \> stage 2 according to Bell, feeding problems with need for parental feeding (days with parental feeding after inclusion), body weight (gain, length), head circumference |
| Secondary | Neurological outcome measures | During first hospital admittance or at term equivalent age (37-42 weeks postmenstrual age), average 3 months | Intraventricular hemorhage(IVH) (all grades, grade III-IV, venous infarction), clinical seizures, periventricular leucomalacia (PVL) \> gr 1) |
| Secondary | Complications during neonatal period | During first hospital admittance or at term equivalent age (37-42 weeks postmenstrual age), average 3 months | Incidence of late onset sepsis (culture proven or clinical suspected) and meningitis after inclusion, need for inotropes/circulatory support |
| Secondary | Retinopathy of prematurity | During first hospital admittance or at term equivalent age (37-42 weeks postmenstrual age), average 3 months | Grade of retinopathy (including plus disease and need for therapy) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37817255 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04430790
GET https://conductscience.org/api/trials/v1/NCT04430790/registered