Radiological Markers for PDA Management in Preterm Infants

NCT07812064 | Not Yet Recruiting

• 1 other identifier: NRMFPTMIPI
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Patent Ductus Arteriosus in Preterm Infants

Keywords

patent Ductus arteriosus; PDA; preterm infants

Outcome Measures

Primary Outcomes (1)

• PDA neonates survival without major morbidity.

  Composite of survival without major morbidity until 36 weeks PMA or discharge: * No BPD (oxygen/respiratory support at 36 weeks PMA). * No NEC ≥ Bell stage II. * No IVH ≥ grade II (Papile classification). * No death.

  one year

Study Arms (2)

Group 1 (Intervention): Echo and Organ Doppler-guided management

ACTIVE COMPARATOR

GROUP 1: INTERVENTION (Echo and Doppler-Guided) Initial Assessment (24-72 hours) All infants in the intervention group undergo: 1\. Comprehensive Echocardiography Timing of Assessments * T0: 24-72 hours of life (baseline). * T1: Prior to PDA treatment (if hsPDA diagnosed in Intervention group). * T2: 24-48 hours after treatment. * All scans are performed by the principal investigator (neonatologist) using a standardized protocol. Images and Doppler traces are stored for quality control. ECHO parameters: Include a statement on hemodynamic significance based on 5 parameters: 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. 2\. Organ Doppler (Superior mesenteric artery (SMA) and Middle cerebral artery (MCA)

Diagnostic Test: Organ doppler; Diagnostic Test: Echocardiography

GROUP 2: CONTROL (Standard Clinical + Echo-Guided)

OTHER

Step 1: Initial assessment (24-72 hours) and classification based on clinical criteria and Echo (without doppler): * Clinical criteria: * Oxygen requirement \>30% OR * Respiratory support (CPAP/ventilator) OR * Wide pulse pressure (\>25 mmHg) OR * Bounding pulses. * Echo criteria: 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. Step 2: Treatment Decision Patients with both clinical signs and echocardiographic evidence of a significant PDA were classified as hsPDA and received pharmacological treatment. In contrast, patients with no clinical signs and/or non-significant echocardiographic findings were classified as non-significant PDA and received supportive care only. This approach was based on traditional clinical and echocardiographic criteria without organ Doppler assessment.

Diagnostic Test: Organ doppler

Interventions

Organ doppler DIAGNOSTIC_TEST

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)

GROUP 2: CONTROL (Standard Clinical + Echo-Guided); Group 1 (Intervention): Echo and Organ Doppler-guided management

Echocardiography DIAGNOSTIC_TEST

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.

Group 1 (Intervention): Echo and Organ Doppler-guided management

Eligibility Criteria

• Age: 0 Hours - 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \<34 weeks and/or birth weight \<1800 g.
• Admitted to the NICU at Assiut University Children Hospital within the first 24 hours of life.
• First echocardiographic assessment performed between 24 and 72 hours of life.

You may not qualify if:

• Major congenital heart disease other than PDA (e.g., coarctation, critical left heart lesions).
• Life-limiting congenital anomalies or chromosomal disorders.
• Severe septic shock or multiorgan failure at time of first assessment.
• Death or transfer before completion of initial Echo and Doppler (\<24 hours of life).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Mifflin J, Makoni M, Chatmethakul T, McNamara PJ, Bischoff AR. Cerebral and intestinal Doppler patterns according to patent ductus arteriosus shunt characteristics in preterm infants. J Perinatol. 2026 Mar;46(3):349-357. doi: 10.1038/s41372-025-02505-9. Epub 2025 Nov 24.

  PMID: 41286416 RESULT

• Winners, O., Machry, J., Luciano, A., Encarnacion, R., Thompson, J., & Beaulieu, M. J. (2023). Diagnosis and Management of Patent Ductus Arteriosus in Preterm Neonates Clinical Pathway Diagnosis and Management of Patent Ductus Arteriosus in Preterm

  RESULT

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Yosra Alaa Khallaf, Assistant Lecturer

CONTACT

0201092683198; yosra.20134501@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: A randomized controlled trial (RCT). Two groups: * Group 1 (Intervention): Echo and Organ Doppler-guided management * Group 2 (Control): Standard clinical with Echo-guided management (no Doppler)

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09