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Comparison of Bosentan and Sildenafil in the treatment of persistent pulmonary hypertension of the newborn

Comparison of Bosentan and Sildenafil in the treatment of persistent pulmonary hypertension of the newborn

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190127042504N1
Enrollment
50
Registered
2019-02-22
Start date
2017-06-16
Completion date
Unknown
Last updated
2019-02-25

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

Conditions

Persistent pulmonary hypertension of newborn. Persistent pulmonary hypertension

Interventions

Intervention 1: Intervention group 1: Newborns with PPHN treated with Bosentan tablet 1mg/kg/dose every 12 hours through PG until 1 mounths. Intervention 2: Intervention group2 : Newborns with PPHN tr

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

Inclusion criteria: All new borns with respiratory distress, decreased of Sat o2 and cyanossies admitted to the NICU of Akbarabadi and Ali Asghar hospital If the echocardiography findings are based on pulmonary artery pressure higher than or equal to 25 mmHg The severity of tricuspid valve regurgitation higher than or equal to 30 mmHg with or without right to left shunt Obtaining the consent of the parents

Exclusion criteria

Exclusion criteria: Other cyanotic heart disease No other cyanotic justifying disease PPHN is not due to pneumonia or meconium aspiration

Design outcomes

Primary

MeasureTime frame
Pulmonary artery pressure. Timepoint: At the start of study and then 1week after. Method of measurement: Echocardiography.

Secondary

MeasureTime frame
Comparison of the duration of treatment in the two groups. Timepoint: daily visit. Method of measurement: Physical examination.;Comparison of the duration of O2 as needed in two groups. Timepoint: Daily visit. Method of measurement: Pulseoximetery.;Comparrison of side effect in 2 groups. Timepoint: Daily visit,weekly labratory test. Method of measurement: Blood pressure,labratory.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaba Farhangdoust

Iran University of Medical Sciences

farhangdoust1980@yahoo.com+98 21 2261 7959

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026