Trial · NCT05527704
the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
NCT05527704, Phase 3, Active not recruiting, Medical University of Warsaw
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial). Trials, record NCT05527704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05527704
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
- NCT number
- NCT05527704
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 608 participants, estimated
- Lead sponsor
- Medical University of Warsaw
- Conditions
- TTN, Respiratory Failure, PPHN
- Interventions
- Salbutamol, 0,9% Chloride Sodium
- First posted
- 2022-09-02
- Last updated
- 2025-11-18
- Other registries' IDs
- eudract:2020-003913-36
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Persistent Pulmonary Hypertension of the Newborn (PPHN) | 7 days of life | PPHN defined as the need for ventilation with FiO2 \>0.30 and features of increased pulmonary pressure on echocardiogram |
| Secondary | the severity of respiratory distress | 48 hrs of life | assessed with the modified TTN Silverman score |
| Secondary | need for intubation | 7 days of life | frequency of need for intubation |
| Secondary | duration of ventilation | 7 days of life | duration of ventilation e.g. non-invasive ventilation |
| Secondary | duration of hospitalization | up to first month of life | duration of hospitalisation after birth |
Source ClinicalTrials.gov
Outcomes0
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 |
|---|---|
| 36714639 | DERIVED |
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/NCT05527704
GET https://conductscience.org/api/trials/v1/NCT05527704/registered