Patent ductus arteriosus (PDA) treatment in premature infants

Oral paracetamol versus oral ibuprofen for the treatment of patent ductus arteriosus in preterm infants: A randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12302923

Enrollment

Registered

2017-02-17

Start date

2015-03-01

Completion date

Unknown

Last updated

2017-10-30

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

Conditions

Patent ductus arteriosus (PDA) Circulatory System Patent ductus arteriosus (PDA)

Interventions

Participants are randomly allocated to receiving either oral paracetamol or oral ibuprofen. Randomisation is done through a computer generated numbers placed in opaque envelopes with sequential number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Premature infants born 32 weeks gestation or earlier 2. Newborns with birth weight 1500 g or under

Exclusion criteria

Exclusion criteria: 1. Ductal dependent congenital heart diseases 2. Major congenital malformation 3. Grade 3-4 intraventricular hemorrhage 4. Renal impairment defined as Creatinine > 1.5 mg/dl 5. Pulmonary hemorrhage 6. Thrombocytopenia < 60.000 /mm 3 7. Elevated Alanine transaminase (ALT)

Design outcomes

Primary

Measure	Time frame
1. Closure of PDA is measured by an echocadiograph within 24 hours post treatment 2. Mortality is assessed through daily follow up of the patients and their medical records.	—

Secondary

Measure	Time frame
1. Respiratory distress syndrome (RDS) is measured using physical examination for clinical signs of respiratory distress and chest X-ray finding at baseline 2. Bronchopulmonary dysplasia (BPD) is measured using clinical examination of the patient for the need of respiratory support or supplemented oxygen at 36 weeks post conceptional age 3. Mechanical ventilation (MV) is measured using clinical examination and reviewing patient record any time during hospital stay until discharge 4. Necrotizing enterocolitis (NEC) is measured using abdominal X-ray for the presence of pneumatosis intistinalis any time during hospital stay 5. Retinopathy of prematurity (ROP) is measured using binocular indirect ophthalmoscopy exam at 32 weeks post conceptional age for premature infants born 28 weeks gestation 6. Intraventricular hemorrhage (IVH) is measured using trans-fontanel cranial ultrasound at 7 days of age 7. Periventricular leukomalacia (PVL) is measured using trans-fontanel cranial ultrasound at one month of age	—

Measure

Time frame

1. Respiratory distress syndrome (RDS) is measured using physical examination for clinical signs of respiratory distress and chest X-ray finding at baseline 2. Bronchopulmonary dysplasia (BPD) is measured using clinical examination of the patient for the need of respiratory support or supplemented oxygen at 36 weeks post conceptional age 3. Mechanical ventilation (MV) is measured using clinical examination and reviewing patient record any time during hospital stay until discharge 4. Necrotizing enterocolitis (NEC) is measured using abdominal X-ray for the presence of pneumatosis intistinalis any time during hospital stay 5. Retinopathy of prematurity (ROP) is measured using binocular indirect ophthalmoscopy exam at 32 weeks post conceptional age for premature infants born 28 weeks gestation 6. Intraventricular hemorrhage (IVH) is measured using trans-fontanel cranial ultrasound at 7 days of age 7. Periventricular leukomalacia (PVL) is measured using trans-fontanel cranial ultrasound at one month of age

—

Countries

Jordan

Outcome results

None listed

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