Skip to content

Evaluation of frequency occurrence persistent pulmonary hypertension of newborns in group of newborns born between 32 and 42 weeks of pregnancy treated by salbutamol

Status
Completed
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515216-46-00
Acronym
REFSAL
Enrollment
608
Registered
2024-12-16
Start date
2021-11-15
Completion date
2025-11-04
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathing disorders as a cause of neonatal respiratory failure

Brief summary

Assessment of the incidence of PPHN defined as the need for ventilation with additional oxygen fraction in the respiratory mixture (FiO2) > 0. 30 and echocardiographic features of elevated pulmonary pressure or the difference in pre and postprandial saturation > 10%

Detailed description

1. Scoring on the TTN score., 2. Prevalence of failures defined as the need for intubation., 3. Duration of respiratory support., 4. Hospitalisation time., 5. Results of the acid-base balance (ABS) and ionogram., 6. Occurrence of Adverse Events.

Interventions

Sponsors

Medical University Of Warsaw
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Assessment of the incidence of PPHN defined as the need for ventilation with additional oxygen fraction in the respiratory mixture (FiO2) > 0. 30 and echocardiographic features of elevated pulmonary pressure or the difference in pre and postprandial saturation > 10%

Secondary

MeasureTime frame
1. Scoring on the TTN score., 2. Prevalence of failures defined as the need for intubation., 3. Duration of respiratory support., 4. Hospitalisation time., 5. Results of the acid-base balance (ABS) and ionogram., 6. Occurrence of Adverse Events.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026