A clinical trial to study the effect of two drugs (paracetamol and indomethacin) in premature newborn babies with patent ductus arteriosus

Randomized control trial of a comparison of enetral paracetamol and intravenous indomethacin for closure of patent ductus arteriosus in preterm newborns - POINT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/12/003163

Enrollment

Registered

2012-12-03

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- Premature newborn infants with patent ductus arteriosus

Interventions

Intervention1: Paracetamol drops: Paracetamol drops 15 mg/kg/dose 6 hourly orally for 7 days Control Intervention1: Inj Indomethacin: Inj Indomethacin 0.2 mg/kg/dose IV once a day for 3 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Birth weight lee than or equal to 1500 grams 2. Echocardiographic within first 48 hours of life showing PDA size 1.5 mm or more

Exclusion criteria

Exclusion criteria: 1.Unable to administer study drug within first 48 hours of life 2.Structural heart disease other than ASD and VSD 3. Antenatal identified structural renal disease 4. Dysmorphic features or congenital anomalies likely to affect life expectancy or neurological development 5. Maternal tocolytic therapy with Indomethacin within 72 hours prior to delivery 6. Overt bleeding at more than one site 7. Platelet count less than 50000 8. Hydrops 9. Not considered viable

Design outcomes

Secondary

Measure	Time frame
1.Renal Impairment 2. GI Bleeding and perforation 3. NEC 4. IVH 5. PVL 6. Pulmonary Hemorrhage 7. ROP 8. Additional course of Indomethacin 9. Surgical closure of PDA 10. CLD Timepoint: Prior to discharge from Hospital	—

Primary

Measure	Time frame
PDA Closure RateTimepoint: PDA Closure Rate	—

Countries

India

Contacts

Public ContactDr Nandkishor S Kabra

Surya Childrens Hospital

dashswarup@ymail.com9819029990

Outcome results

None listed

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