Ductus Arteriosus, Patent
Conditions
Keywords
patent ductus arteriosus, PDA, Preterm, Infant, Electrocardiography, Paracetamol, Acamol, ibuprofen, Placebo
Brief summary
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.
Detailed 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.
Interventions
DRUGParacetamol
Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h
DRUGPlacebo
Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Days to 2 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of patent ductus arteriosus closure | 3-10 days after first dose of Ibuprofen + study drug | By echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | until discharge home (usually within 2-3 months since recruitment) | Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records |
| The need for surgical ligation for PDA | 3-21 days after first dose of Ibuprofen + study drug | need for surgical ligation for PDA |
Countries
Israel
Outcome results
None listed