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The three options for the treatment of patent ductus arterioles (PDA) in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants.
Patent ductus arteriosus (PDA), of which incidence is inversely related to gestational age and birth weight, is one of the the most common conditions among preterm infants.
In recent years, the use of antenatal steroids, postnatal surfactant, noninvasive ventilation strategies and low oxygen saturation targets have affected the incidence of hemodynamically significant PDA (HSPDA). There is not any consensus about the best approach on the clinical management of PDA in preterm infants. Over past years, the management of HSPDA shifted to aggressive medical and surgical intervention from conservative treatment, but conservative treatment approach has been mainly concerned again nowadays.
Today, the three options for the treatment of PDA in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants. Many countries including developed countries only give recommendations, instead of publishing guidelines, on screening, timing of treatment and treatment choices of PDA, because of the differences on management of PDA between the centers even within a single center.
Timing of PDA treatment and treatment choices at preterm infants born before 28 gestation weeks' differ in our country also in many countries over the world. In this study, it is aimed to record the managements of PDA detected beyond postnatal 3 days, to compare the effects of the managements at postnatal 3-7 days and after 7 days on closure, surgical ligation rates and side effects of drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Management at PN 3-7 days | Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated at 3-7 days of their life |
| |
| Management after PN 7 days | Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated beyond 7 days of their life |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Device | Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontan closure rate | Rate of patients with spontaneous ductal closure | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical ligation rate | rate of patients who need surgical ligation for hemodynamically significant ductus | 3 months |
| Complications of prematurity | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Infants born at 24 0/7-28 6/7 gestation weeks' who were performed echocardiography at or after postnatal 72 hours of life, and detected ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 are the candidates for the study. The management of PDA and the other data of these infants will be registered to online registry system.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ömer Erdeve, Professor | Contact | +90-505-4812151 | omererdeve@yahoo.com | |
| Emel Okulu, Attending | Contact | +90-505-2530974 | emelokulu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ömer Erdeve, Professor | Ankara University | Principal Investigator |
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No data individual data will be shared
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |