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Babies who are born very prematurely are often born with murmurs in the heart. In preterm babies, one of the most common causes of murmur is the presence of a PDA. This is the persistence of a connection that normally exists in the baby before it is born, connecting between the major blood vessels that leave the heart. In term babies, this channel closes shortly after birth when normal adult circulation is achieved. However, in preterm babies, the PDA can remain open, which can lead to multiple problems in the baby.
Our current standard of treatment in the Neonatal Intensive Care Unit (NICU) is to perform cardiac ultrasound (echocardiogram) in all babies less than 29 weeks gestation to diagnose the presence of hsPDA. We also use an echocardiogram to follow the PDA until complete closure. If present, the standard treatment in the NICU is to give medication, usually Ibuprofen, a non-steroidal anti-inflammatory drugs (NSAID), to close the PDA.
Near-infrared spectroscopy (NIRS) is a new type of device to detect oxygenated blood supply to the brain, kidney, and abdominal regions. This device is used to assess the effects of Ibuprofen on oxygen supply to these three regions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 infants | Active Comparator | (n=15) will receive three doses of standard-dose Ibuprofen. (10-5-5 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses |
|
| Group 2 infants | Active Comparator | (n = 15) will receive three doses of high-dose Ibuprofen Motrin. (20-10-10 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Dose Ibuprofen | Drug | (10-5-5 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in regional tissue oxygenation (splanchnic, cerebral, and the splanchnic-cerebral oxygenation ratio 'SCOR') during hsPDA treatment | with the first 28 days after enrolment | |
| Change in splanchnic, cerebral, and renal Doppler blood flow during hsPDA treatment [Peak Systolic Velocity (PSV), End Diastolic Velocity (EDV), and Resistive Index (RI)] | with the first 28 days after enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Necrotizing Enterocolitis (NEC): > 2 (Modified bell's Criteria) | with the first 28 days after enrolment | |
| Spontaneous intestinal perforation (SIP) | with the first 28 days after enrolment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadya Ben Fadel, MD | Contact | 613-737-7600 | 3716 | nbenfadel@cheo.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa General Hospital | Recruiting | Ottawa | Canada |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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The investigators are equipped with unique and complementary expertise that will propel this promising work forward. We will recruit 30 preterm infants less than (<)29 weeks gestation at birth with echocardiographic evidence of hsPDA that require pharmacologic treatment. We will examine renal, cerebral, intestinal blood flow and tissue oxygenation in high-risk preterm infants receiving high dose or standard-dose Ibuprofen treatment for hsPDA. Successful completion of this study will establish feasibility and provide proof-of-concept for a future multi-center trial. We will use descriptive statistics to compare patients' characteristics. To compare NIRS and Doppler data between the two groups, we will use paired t-test if data is normally distributed or Wilcoxon signed-rank test if not normally distributed
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| High Dose Ibuprofen | Drug | (20-10-10 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses |
|
| Incidence of oliguria |
| (<1 ml/kg/hour for > 12 hours) |
| Feeding intolerance | we define feeding intolerance as the decision by the managing team to withhold feeds for at least 24 hours in the absence of definite evidence of medical or surgical NEC | with the first 28 days after enrolment |
| Gastrointestinal bleeding | Any amount of visible bright red or altered blood in emesis, nasogastric tube, or feces | with the first 28 days after enrolment |
| Pulmonary hemorrhage | with the first 28 days after enrolment |
| Presence of echocardiographic features of pulmonary hypertension | with the first 28 days after enrolment |