Patent ductus arteriosus (PDA) treatment in premature infants

• Register: ISRCTN
• Last refreshed on: 30 October 2017
• Main ID: ISRCTN12302923
• Date of registration: 17/02/2017
• Prospective Registration: No
• Primary sponsor: University of Jordan
• Public title: Patent ductus arteriosus (PDA) treatment in premature infants
• Scientific title: Oral paracetamol versus oral ibuprofen for the treatment of patent ductus arteriosus in preterm infants: A randomized trial
• Date of first enrolment: 01/03/2015
• Target sample size: 10
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN12302923
• Study type: Interventional
• Study design: Single-centre randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Jordan

Contacts

• Name: Manar Al-lawama

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 numbers.

Group 1 (oral paracetamol): Participants receive 10 mg/kg/dose of paracetamol orally (as a syrup) followed by 1-2 cc 0/9% saline every six hours for three days.

Group 2 (oral ibuprofen group): Participants receive 10mg/kg/dose of ibuprofen orally (as a syrup) followed by 1-2 cc 0.9% saline once daily for three days.

An echocardiogram is done within 24 hours of last treatment dose to assess the PDA. If the treatment fails, another course of the same assigned drug is given. If the treatment fails after the second course of the same drug, the patient will receive the drug from the other group. Participants are followed up if there are respiratory distress symptoms.

Primary Outcome(s)

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 Outcome(s)

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 or at 4 weeks chronological 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

Source(s) of Monetary Support

University of Jordan