Conservative management of ductus in preterm neonates

Conservative management of patent ductus arteriosus in preterm neonates below 32 weeks gestation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012784

Enrollment

298

Registered

2018-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Preterm neonates below 32 weeks gestation

Interventions

Intervention1: Medical treatment of hemodynamically significant PDA: oral ibuprofen or intravenous paracetamol will be given to eligible neonates if hemodynamic significant PDA is present (duct size 1

Eligibility

Inclusion criteria

Inclusion criteria: All of following 1.Neonates with gestational age below 32 weeks, 2.Receiving mechanical ventilation 3.Having patent ductus arteriosus with duct diameter >1.5 and left atrium to aottic root ratio >1.5

Exclusion criteria

Exclusion criteria: 1.Neonates with congenital heart disease 2.Neonates with persistent pulmonary hypertension of newborn 3.Failure to obtain parental consent

Design outcomes

Primary

Measure	Time frame
Death or moderate to severe broncho-pulmonary dysplasiaTimepoint: at discharge from NICU	—

Secondary

Measure	Time frame
Duration of mechanical ventilationTimepoint: discharge from NICU;intraventricular hemorrhageTimepoint: discharge from NICU;moderate to severe hearing lossTimepoint: discharge from NICU;mortality during NICU stayTimepoint: discharge from NICU;necrotizing enterocolitisTimepoint: discharge from NICU;Periventricular leucomalaciaTimepoint: discharge from NICU;pharmacological treatment for PDATimepoint: discharge from NICU;Retinopathy of prematurityTimepoint: discharge from NICU;Surgical ligations for PDATimepoint: discharge from NICU;use of postnatal steroids for facilitation of extubationTimepoint: discharge from NICU	—

Measure

Time frame

Duration of mechanical ventilationTimepoint: discharge from NICU;intraventricular hemorrhageTimepoint: discharge from NICU;moderate to severe hearing lossTimepoint: discharge from NICU;mortality during NICU stayTimepoint: discharge from NICU;necrotizing enterocolitisTimepoint: discharge from NICU;Periventricular leucomalaciaTimepoint: discharge from NICU;pharmacological treatment for PDATimepoint: discharge from NICU;Retinopathy of prematurityTimepoint: discharge from NICU;Surgical ligations for PDATimepoint: discharge from NICU;use of postnatal steroids for facilitation of extubationTimepoint: discharge from NICU

—

Countries

India

Contacts

Public ContactDr Manoj Modi

Sir Ganga Ram Hospital

drmanojmodi@gmail.com9873266331

Outcome results

None listed

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