To compare early routine medical treatment for unclosed hole in the heart to protocol based treatment in preterm newborns 28 weeks gestation

To compare early routine pharmacologic treatment of hemodynamically significant patent ductus arteriosus (PDA) to a conservative approach as per McNamara criteria for extreme preterms (less than 28 weeks gestation age): a randomized control non inferiority trial. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072703

Enrollment

106

Registered

2024-08-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I00-I99- Diseases of the circulatory system

Interventions

Intervention1: Intervention: No treatment of HSPDA To treat only if McNamara stage more than C3E3 Switch over in case of certain indications Control Intervention1: control: receiving intravenous par

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants with gestational age less than 28 weeks with hsPDA as defined by: Duct size more than 1.5mm (narrowest internal diameter) Left atrium/aorta more than 1.4 E/A >1 Antegrade left pulmonary artery diastolic flow >30 cm/sec

Exclusion criteria

Exclusion criteria: Infants having complex cyanotic heart disease or duct dependent cardiac lesion. Infants who were admitted to hospital after 72 hours of life. Antenatal diagnosed lethal congenital anomaly. Maternal tocolytic therapy with indomethacin or another prostaglandin inhibitor within 72 hours prior to delivery.

Design outcomes

Primary

Measure	Time frame
PDA closure rate Timepoint: 4 weeks	—

Secondary

Measure	Time frame
bronchopulmonary dysplasiaTimepoint: 60 days;Ductal reopening during NICU stay.Timepoint: 28 days;Duration of hospital stayTimepoint: 90 days-120 days;early and late onset sepsisTimepoint: 28 days;intraventricular hemorrhage grade 2 or moreTimepoint: 28 days;MortalityTimepoint: 120 days;necrotizing enterocolitisTimepoint: 28 days;Need for second course of medical treatment for PDATimepoint: 28 days;Number of days on invasive or non invasive ventilation/ oxygen therapy.Timepoint: 60 days;periventricular leukomalaciaTimepoint: 60 days;Persistent ductus needing surgical interventionTimepoint: 28 days;pulmonary haemorrhageTimepoint: 28 days;retinopathy of prematurityTimepoint: 60 days;time to reach full enteral feedsTimepoint: 28 days	—

Measure

Time frame

bronchopulmonary dysplasiaTimepoint: 60 days;Ductal reopening during NICU stay.Timepoint: 28 days;Duration of hospital stayTimepoint: 90 days-120 days;early and late onset sepsisTimepoint: 28 days;intraventricular hemorrhage grade 2 or moreTimepoint: 28 days;MortalityTimepoint: 120 days;necrotizing enterocolitisTimepoint: 28 days;Need for second course of medical treatment for PDATimepoint: 28 days;Number of days on invasive or non invasive ventilation/ oxygen therapy.Timepoint: 60 days;periventricular leukomalaciaTimepoint: 60 days;Persistent ductus needing surgical interventionTimepoint: 28 days;pulmonary haemorrhageTimepoint: 28 days;retinopathy of prematurityTimepoint: 60 days;time to reach full enteral feedsTimepoint: 28 days

—

Countries

India

Contacts

Public ContactDr Anitha Haribalakrishna

Seth GSMC and KEM Hospital, Mumbai

ani.gem81@gmail.com9769660870

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026