Clinical Trial on Infant, Newborn, Diseases, Hypertension, Pulmonary - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Aya s Mohamed, Resident
Phone Number: +20 10 20640170
Email: ayat.18313253@med.aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Term and preterm neonates admitted to the Neonatal Intensive Care Unit of Assiut University Children Hospital with clinical and echocardiographic evidence of persistent pulmonary hypertension.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single cohort: Neonates with PPHN Term and preterm neonates with clinical and echocardiographic evidence of persistent pulmonary hypertension who will be followed for clinical, laboratory, and echocardiographic predictors of outcome.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Chair: Nagwa A Mohammed, prof, pediatrics Department, Assiut University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2026

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted