NCT07820163

Brief Summary

This prospective observational study aims to evaluate the agreement between prenatal fetal echocardiographic diagnoses and postnatal diagnoses of congenital heart disease, and to assess the impact of prenatal diagnosis status on neonatal clinical outcomes at Assiut University Hospitals.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026May 2028

First Submitted

Initial submission to the registry

September 2, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 2, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2028

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

September 2, 2026

Last Update Submit

September 14, 2026

Conditions

Congenital Heart DiseaseNeonatal DiseaseFetal Heart DisorderFetal Disease

Keywords

Neonatal outcomesCongenital heart diseaseFetal echocardiographyPerinatal cardiologyPrenatal diagnosis

Outcome Measures

Primary Outcomes (1)

  • Agreement between prenatal and postnatal CHD diagnosis

    Proportion of cases with complete agreement between prenatal fetal echocardiographic diagnosis and postnatal confirmed diagnosis of congenital heart disease.

    Up to 30 days

Secondary Outcomes (4)

  • Neonatal all-cause mortality

    Up to 30 days

  • Rate of unplanned emergency cardiac intervention

    Up to 30 days

  • Duration of NICU stay

    Up to 30 days

  • Need for emergency delivery room intervention

    Baseline

Study Arms (3)

Neonates with prenatally diagnosed CHD managed with structured perinatal care plan

Neonates with prenatally diagnosed CHD managed with structured perinatal care plan

Neonates with CHD first diagnosed postnatally

Neonates with CHD first diagnosed postnatally

Neonates with CHD transferred from external centers after birth

Neonates with CHD transferred from external centers after birth

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women referred for fetal echocardiography due to suspected or confirmed congenital heart disease, and neonates with prenatally or postnatally confirmed CHD at Assiut University Hospitals.

You may qualify if:

  • \- Term neonates with confirmed critical CHD
  • Neonates with prenatal CHD diagnosis or postnatal first-time diagnosis
  • Parental written informed consent
  • Singleton pregnancies referred for fetal echocardiography between 18 and 36+6 weeks
  • Suspected cardiac abnormalities on routine obstetric scan
  • Written informed consent

You may not qualify if:

  • \- Multiple gestations
  • Fetuses with growth restriction (EFW or AC below 3rd percentile)
  • Premature infants (\<37 weeks)
  • Neonates with stable CHD not requiring intervention
  • Incomplete records or loss to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Patel SR, Michelfelder E. Prenatal Diagnosis of Congenital Heart Disease: The Crucial Role of Perinatal and Delivery Planning. J Cardiovasc Dev Dis. 2024 Mar 31;11(4):108. doi: 10.3390/jcdd11040108.

    PMID: 38667726BACKGROUND

  • Blazquez-Romero MDV, Mendivil-Carboni M, Sarasquete-Martinez M, Sainz-Agost A, Falo F, De Corato M, Gomez-Benito MJ. Periodic confined cell migration drives partially reversible chromatin reorganization in cancer cell lines. Commun Biol. 2026 Feb 6;9(1):366. doi: 10.1038/s42003-026-09637-4.

    PMID: 41652104BACKGROUND

  • Esmaeilzadeh Z, Eaton DW, Hosseini N, Zeinabady D. Sealing faults and fluid-induced seismicity. Philos Trans A Math Phys Eng Sci. 2024 Jul 23;382(2275):20230418. doi: 10.1098/rsta.2023.0418. Epub 2024 Jul 1.

    PMID: 38910408BACKGROUND

  • Li Y, Guan X, Lan T, Zhang ZR, Zhang Y, Jiang S, Li M, Shi FD, Jin WN. The miR-451a facilitates natural killer cell-associated immune deficiency after ischemic stroke. J Cereb Blood Flow Metab. 2025 Jul;45(7):1371-1384. doi: 10.1177/0271678X251321641. Epub 2025 Feb 22.

    PMID: 39985210BACKGROUND

MeSH Terms

Conditions

Heart Defects, CongenitalInfant, Newborn, DiseasesFetal Diseases

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Duaa M Raafat, prof

    Pediatric Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Amany A Kamel, Resident

CONTACT

+20 12 00676179Amani.18313462@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician Department of Pediatrics

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 15, 2026

Study Start

September 2, 2026

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

May 25, 2028

Last Updated

September 16, 2026

Record last verified: 2026-09