Effectiveness and safety of IV terlipressin as an add-on treatment for persistent pulmonary hypertension of the newborn

Effectiveness and safety of IV terlipressin as an add-on treatment for persistent pulmonary hypertension of the newborn: a multicenter pragmatic randomized controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600122623

Enrollment

Unknown

Registered

2026-04-15

Start date

2026-04-15

Completion date

Unknown

Last updated

2026-04-20

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

Interventions

Control group: iNO:inhaled nitric oxide

Intervention group: iNO+TP:terlipressin in addition to iNO therapy

Eligibility

Sex/Gender

All

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosis of PPHN; 2.Gestational age at birth >= 34 weeks; 3.Birth weight >= 2000 g; 4.Age =16; 6.Mean arterial pressure (MAP) =36 weeks.

Exclusion criteria

Exclusion criteria: 1.Presence of the following diseases or pathological conditions: Complex congenital heart disease (except patent ductus arteriosus or small atrial septal defect), cyanotic heart disease dependent on right-to-left shunting, or left heart dysfunction (manifested by elevated left atrial pressure with left-to-right atrial shunting and right-to-left ductal shunting); Congenital diaphragmatic hernia; Chromosomal abnormalities, inherited genetic disorders, or congenital methemoglobinemia; Suspected alveolar-capillary dysplasia; Other severe congenital malformations; Hemodynamic instability or temporary need for blood transfusion; Uncontrolled coagulation disorders or untreated thrombocytopenia (platelet count <50,000/µL); History of severe (grade 3 or 4) intracranial hemorrhage. 2.Infants who experienced severe asphyxia or seizures before enrollment. 3.Infants judged by the clinical team to be critically ill: Expected to die within 24 hours; Require immediate cardiopulmonary resuscitation or ECMO; Have severe abnormalities of the brain, heart, or thorax that threaten life. 4.Any other conditions deemed unsuitable for participation by the investigators.

Design outcomes

Primary

Measure	Time frame
Extracorporeal Membrane Oxygenation;Death;	—

Secondary

Measure	Time frame
Abnormal Liver Function;hyponatremia;hypertension;Systolic pulmonary artery pressure;PaO2/FiO2;Thrombocytopenia;Additional pulmonary vasodilator use;Oxygenation Index;iNO treatment duration;Pre- and post-ductal SpO?;methemoglobinemia;Abnormal Renal Function;Oliguria;	—

Countries

China

Contacts

Public ContactLinan Zeng

West China Second University Hospital of Sichuan University (WCSUH- SCU)

egg16@aliyun.com+86 28 8550 3205

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026