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Not yet recruitingNCT07822750Updated Sep 16, 2026

Predictors of Outcomes in Pulmonary Hypertension of the Newborn

An observational study in Hypertension, Pulmonary and Infant, Newborn, Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
Up to 28 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension, Pulmonary
  • Infant, Newborn, Diseases

Keywords

  • hypertension of the newborn
  • Neonatal outcomes
  • PPHN
  • Mortality
  • Persistent pulmonary
  • Echocardiography
  • Assiut
03

In context

Hypertension, Pulmonary

1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.

This study's planned enrollment of 60 is below the median of 110 across 381 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 28 Days
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • - Major structural cyanotic congenital heart disease
  • Lethal congenital anomalies or chromosomal abnormalities incompatible with survival
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. In-hospital mortality

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

    Time frame: Up to 30 days

Secondary outcomes

  1. Duration of mechanical ventilation

    Total number of days of invasive mechanical ventilation.

    Time frame: Up to 30 days

  2. Duration of oxygen therapy

    Total number of days requiring supplemental oxygen.

    Time frame: Up to 30 days

  3. Use of sildenafil

    Proportion of neonates who receive sildenafil therapy.

    Time frame: Up to 30 days

  4. Use of inotropes

    Proportion of neonates who receive inotropic support

    Time frame: Up to 30 days

  5. Duration of NICU stay

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

    Time frame: Up to 30 days

  6. Time to echocardiographic resolution

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

    Time frame: Up to 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Reid H, Hocking C, Smythe E. Occupational therapy's oversight: How science veiled our humanity. Scand J Occup Ther. 2024 Dec;31(1):2306585. doi: 10.1080/11038128.2024.2306585. Epub 2024 Jan 23. PubMed 38261715 ↗
  • Xiaowan Y, Gang L. Bone Toothbrush Handles in Chinese Tang Dynasty Ash Pits. J Hist Dent. 2024 Summer/Fall;72(2):162-164. doi: 10.58929/jhd.2024.072.02.162. PubMed 39180735 ↗
  • Liu CR, Wan LP, Liu BP, Jia CX, Liu X. Depressive symptoms mediate the association between maternal authoritarian parenting and non-suicidal self-injury among Chinese adolescents. J Affect Disord. 2022 May 15;305:213-219. doi: 10.1016/j.jad.2022.03.008. Epub 2022 Mar 10. PubMed 35278486 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07822750
Lead sponsor
Assiut University
Responsible party
Aya Saleh Mohammed (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 16, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Sep 10, 2027 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Sep 16, 2026

Study contacts

Aya s Mohamed, Resident
Contact
ayat.18313253@med.aun.edu.eg
+20 10 20640170
Nagwa A Mohammed, prof
study chair · pediatrics Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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