This trial is evaluating whether Ibuprofen will improve 2 primary outcomes and 22 secondary outcomes in patients with Patent Ductus Arteriosus After Premature Birth. Measurement will happen over the course of 7 days postnatal age.
This trial requires 100 total participants across 2 different treatment groups
This trial involves 2 different treatments. Ibuprofen is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
"PDA is a normal structure that is present at birth and it resolves spontaneously. However, there are clinical features that suggest a possible clinical problem. PDA, patent does not affect development of cardiovascular or pulmonary abnormalities. PDA, patent is not associated with other cardiovascular abnormalities like aortic coarctions. There are other causes for PDA, patent, and the treatment of PDA, patent is a clinical decision." - Anonymous Online Contributor
"DAP is rarely seen at the present time, but our experience shows that it can be cured once detected. The patients should have complete cardiological investigation with 2DTO by CT or MRI for confirmation. Early correction of DAP, avoiding complications of systemic right ventricular overloading, is essential for their long term survival." - Anonymous Online Contributor
"Signs of ductus arteriosus, patent include cyanosis and hepatomegaly. Ductus arteriosus, patent causes decreased blood volume for the body to deliver to the rest of the body. This will cause cyanosis and swelling. Ductus arteriosus, patent must have some cause and may result when there is a tear or abnormality of the duct. The most likely causes of ductus arteriosus, patent are a congenital defect that may result in either absent or insufficient blood flow to the body from the aorta through the ductus, or may be secondary to trauma to the aorta or ductus. Patients may have decreased oxygen levels to the rest of the body due to decreased blood supply." - Anonymous Online Contributor
"Approximately 60 infants per year require surgery to treat a patent ductus arteriosus in the United States. In the study population, 25% had only one open arterial switch, 37% had one peritoneal shunt, and 42% had a double balloon valve." - Anonymous Online Contributor
"DAP is diagnosed by echocardiogram and/or saturation test when the PA is more than 50%. PAO and LVM are important as predicting factors of DAP." - Anonymous Online Contributor
"For a patent pulmonary artery, echocardiogram, Doppler catheterization, and angiography are appropriate initial assessments. Followup with repeated echocardiograms is not necessary unless the diagnosis is questionable. As for patent ductus arteriosus, a patent ductus arteriosus is best managed by observation with regular echocardiographic and Doppler studies because no treatment is required for most children. For a patent ductus arteriosus with aorta to pulmonary arteries ratio less than or equal to 0.5:1 at 0-6 weeks of life, surgery should be deferred, with most cases undergoing expectant management." - Anonymous Online Contributor
"Infants with a patent ductus arteriosus who receive ibuprofen for at least 14 days are most likely to benefit; less safety is seen with longer dosing and in younger children, and may result in harm. The study results support the safety of prescribing ibuprofen to infants with a patent ductus arteriosus." - Anonymous Online Contributor
"Ibuprofen may reduce pain and fever in newborns with ductus arteriosus, but it does not improve quality of life, as measured by the Neonatal Outcome Questionnaire." - Anonymous Online Contributor
"When used empirically after an ECG is positive for SGA, ductus arteriosus, patent < 4 mm diameter is relatively harmless. Patients with ductus arteriosus, patent 4-5 mm should undergo immediate surgery. This treatment plan is supported by earlier studies demonstrating that ductus arteriosus, patent ≥ 4 mm is one of two best predictors of neonatal death." - Anonymous Online Contributor
"In a family with a high prevalence of ductus arteriosus, patentrun, patients with ductus patentrun and other associated cardiovascular defects have a higher frequency of cardiac malformations such as atrial septal defects, pulmonary valve stenosis, and patent foramen ovale." - Anonymous Online Contributor
"In the absence of clear evidence of benefit, ibuprofen is rarely used in routine practice for the treatment of patent ductus arteriosus. However, it is frequently used where patent ductus arteriosus exists as a part of the multimodal management of infants with neonatal respiratory distress and/or low blood oxygen levels." - Anonymous Online Contributor
"Ibuprofen has a major effect on fetal brain blood flow but has far less effect than aspirin is used in early human pregnancy. Ibuprofen can cause hypoxia at the brain-stem level, although these effects are mild; they would not, as far as knows, be expected to cause neural tube defects. However, ibuprofen treatment in the rat results in increased fetal mortality at a dose of 500 mg per g of bodyweight per day. This dose would not be expected to be used in a human fetus; ibuprofen exposure of pregnant women up to 1." - Anonymous Online Contributor