Predictors of Outcomes in Pulmonary Hypertension of the Newborn

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07822750

Enrollment

Registered

2026-09-16

Start date

2026-09-10

Completion date

2028-02-01

Last updated

2026-09-16

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

Conditions

Hypertension, Pulmonary, Infant, Newborn, Diseases

Keywords

hypertension of the newborn, Neonatal outcomes, PPHN, Mortality, Persistent pulmonary, Echocardiography, Assiut

Brief summary

This prospective cohort study aims to identify the clinical, laboratory, and echocardiographic predictors of outcomes among neonates diagnosed with persistent pulmonary hypertension of the newborn at Assiut University Children Hospital.

Detailed description

Persistent pulmonary hypertension of the newborn (PPHN) is a serious condition characterized by failure of the normal postnatal decline in pulmonary vascular resistance, leading to severe hypoxemia. Outcomes vary widely, ranging from complete recovery to death. This observational study will include term and preterm neonates admitted to the NICU with clinical and echocardiographic evidence of pulmonary hypertension. Clinical, laboratory, and echocardiographic parameters will be recorded to identify predictors of mortality and other adverse outcomes.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

Healthy volunteers

Inclusion criteria

* \- Neonates (term and preterm) admitted to the NICU * Clinical and echocardiographic evidence of pulmonary hypertension * Written informed consent from parents or legal guardians

Exclusion criteria

* \- Major structural cyanotic congenital heart disease * Lethal congenital anomalies or chromosomal abnormalities incompatible with survival

Design outcomes

Primary

Measure	Time frame	Description
In-hospital mortality	Up to 30 days	Proportion of neonates with persistent pulmonary hypertension who die before hospital discharge.

Secondary

Measure	Time frame	Description
Duration of mechanical ventilation	Up to 30 days	Total number of days of invasive mechanical ventilation.
Duration of oxygen therapy	Up to 30 days	Total number of days requiring supplemental oxygen.
Use of sildenafil	Up to 30 days	Proportion of neonates who receive sildenafil therapy.
Use of inotropes	Up to 30 days	Proportion of neonates who receive inotropic support
Duration of NICU stay	Up to 30 days	Length of stay in the neonatal intensive care unit in days.
Time to echocardiographic resolution	Up to 30 days	Number of days from diagnosis until echocardiographic resolution of pulmonary hypertension.

Contacts

CONTACTAya s Mohamed, Resident

ayat.18313253@med.aun.edu.eg+20 10 20640170

STUDY_CHAIRNagwa A Mohammed, prof

pediatrics Department, Assiut University Hospitals

Outcome results