PDA
Conditions
Keywords
Paracetamol, Acetaminophen, PDA, Preterm infants
Brief summary
There is a report that acetaminophen may have a role in pharmacological closure of PDA (Patent arterial duct) in preterm infants. The investigators conducted this open label non randomized and non control study to try to support that report.
Detailed description
In-uteri, the arterial duct connects between the aorta and the main pulmonary artery, thus bypassing the lungs. Since the high pulmonary pressure and the low systemic pressure, the shunt trough the arterial duct in that time is right to left. After birth, systemic pressure rises and pulmonary pressure declines. As oxygen saturation rises, and prostaglandin secretion, the arterial duct closes, usually. In preterm infants, the arterial duct may remain open after birth. At this tume the shunt would be left to right, that would cause pulmonary congestion, and systemic hypoperfusion. Ibuprofen is the treatment of choice for PDA in preterm infants. Yet, ibuprofen is not effective after two weeks of age. Moreover, there are situations that prevent treatment with ibuprofen, such as thrombocytopenia or renal failure. Surgical closure of arterial duct is an alternative treatment, if ibuprofen is contraindicated, or if it fails. Lastly, there was a report that acetaminophen may have a role in pharmacological closure of PDA in preterm infants. The investigators conducted this open label non randomized and non control study to try to support that report.
Interventions
DRUGParacetamol
Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.
DRUGIbuprofen
Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature
PROCEDUREClosure of PDA
Open surgery for closure of PDA
Sponsors
Hillel Yaffe Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Months
Healthy volunteers
No
Inclusion criteria
* Preterm infants with symptomatic PDA who could not be treated with ibuprofen
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Closure of arterial duct - yes / No | 1 week | Echo-cardiogram that will give exact answer to the question: was the arterial duct closed? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for surgical closure of arterial duct | 1 week | The clinical state of the infant will guide the team to ask the parents and the chest surgeon to surgically close the arterial duct |
Other
| Measure | Time frame | Description |
|---|---|---|
| Death or deterioration | 1 week | The infant state deteriorates so quickly that it will die, either because of complication of the arterial duct, or because other causes, such as sepsis, metabolic disorder, etc... |
Countries
Israel
Outcome results
None listed