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NOT YET RECRUITING
NCT07812064
NA

Radiological Markers for PDA Management in Preterm Infants

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

The aim of this Randomized controlled trial is to determine whether Echo with Organ Doppler-guided management strategy for hemodynamically significant patent ductus arteriosus (hsPDA) improves the short-term outcomes compared with standard care in preterm neonates. the research question is Does the usage of new radiological markers minimize the hsPDA group and decrease the pharmacological management in order to decrease the side effects of the treatment ? Researchers will compare the Echo with Organ Doppler management group to the standard care group.

Official title: Novel Radiological Markers for PDA-Targeted Management in Preterm Infants: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

0 Hours - 96 Hours

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2027-01-01

Completion Date

2028-06

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Organ doppler

Organ Doppler (Superior mesenteric artery (SMA) and Middle cerebral artery (MCA)). -Two arteries, one primary parameter: End-diastolic velocity (EDV). \*Definition of abnormal organ Doppler: Any abnormality in SMA or MCA (low EDV or ARDF) (Mifflin et al., 2026)

DIAGNOSTIC_TEST

Echocardiography

Include a statement on hemodynamic significance based on 5 parameters: (Winners et al. (2023). 1. Diameter 2. Flow direction 3. Systolic and diastolic flow velocities 4. Indices of pulmonary over circulation 5. Left ventricular output - Plus, one parameter of left sided volume loading or left heart pressure loading, systemic shunt effect, doppler flow patterns in the systemic circulation.