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The effect of Macitentan compared to Bosentan in neonates with persistent pulmonary hypertension treated with Sildenafil

The effect of Macitentan compared to Bosentan in neonates with persistent pulmonary hypertension treated with Sildenafil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160120026115N9
Enrollment
60
Registered
2022-12-03
Start date
2020-12-30
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Persistent pulmonary hypertension of the newborn. Persistent fetal circulation

Interventions

Intervention 1: Intervention group: Bosentan tablets (manufactured by Faran Shimi, Iran) with a concentration of 1 mg/kg and Sildenafil (Alborz Darou) with a concentration of 0.4 mg /kg every 12 hours

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Months

Inclusion criteria

Inclusion criteria: Parents' satisfaction to participate in the study Newborns with respiratory symptoms, decreased arterial oxygen saturation, and cyanosis Pulmonary artery pressure greater than or equal to 25 mmHg and severity of tricuspid valve failure greater than or equal to 30 mmHg with or without right-to-left shunt

Exclusion criteria

Exclusion criteria: Cyanotic heart diseases Other diseases cyanosis Increased pulmonary artery pressure due to pneumonia or meconium aspiration

Design outcomes

Primary

MeasureTime frame
Persistent Pulmonary Hypertension of the Newborn. Timepoint: The beginning of the study, 6 and 12 days after the intervention. Method of measurement: Echocardiography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSama dabbagh

Iran University of Medical Sciences

S.dabbagh69@yahoo.com+98 21 8843 0783

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026