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NCT Number: NCT07822750

Predictors of Outcomes in Pulmonary Hypertension of the Newborn

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.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypertension Infant, Newborn, Diseases Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. In-hospital mortality

    Time frame: Up to 30 days

    Proportion of neonates with persistent pulmonary hypertension who die before hospital discharge.

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: Up to 30 days

    Total number of days of invasive mechanical ventilation.

  2. Duration of oxygen therapy

    Time frame: Up to 30 days

    Total number of days requiring supplemental oxygen.

  3. Use of sildenafil

    Time frame: Up to 30 days

    Proportion of neonates who receive sildenafil therapy.

  4. Use of inotropes

    Time frame: Up to 30 days

    Proportion of neonates who receive inotropic support

  5. Duration of NICU stay

    Time frame: Up to 30 days

    Length of stay in the neonatal intensive care unit in days.

  6. Time to echocardiographic resolution

    Time frame: Up to 30 days

    Number of days from diagnosis until echocardiographic resolution of pulmonary hypertension.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya s Mohamed, Resident

CONTACT

[email protected]

+20 10 20640170

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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