Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants

Rambam Health Care Campus

Status and phase: Completed; Phase 3; Phase 2

Conditions: Ductus Arteriosus, Patent

Treatments: Drug: Paracetamol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02002741

IBUACA CTIL

Details and patient eligibility

About

The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Full description

Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Enrollment: 24 patients

Sex: All

Ages: 2 days to 2 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants born at 24-37 gestational age
• diagnosis of Hemodynamically significant patent ductus arteriosus
• Medical staff decided to treat with Ibuprofen
• Parents have signed informed consent

Exclusion criteria

• Contraindication for ibuprofen
• Alanine transaminase /Aspartate transaminase≥ 200 U/L
• Significant congenital heart disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Ibuprofen + Paracetamol

Active Comparator group

Description:

Ibuprofen 10mg/kg once --\> 5mg/kg twice, q 24h for total of 3 doses + Intravenous Paracetamol : Loading dose 20mg/kg --\> 10 mg/kg q6h for total of 12 doses

Treatment:

Drug: Paracetamol

Ibuprofen + Placebo

Placebo Comparator group

Description:

Ibuprofen 10mg/kg once --\> 5mg/kg twice, q 24h for total of 3 doses + Placebo (NaCl 0.9%) , Intravenous , at equal volume to the paracetamol in the paracetamol arm, total of 12 doses given q 6h.

Treatment:

Drug: Placebo