Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure

Study Overview
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Brief Summary
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The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.

Detailed Description
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Infants with birth weight at <1200gm and/or <28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to treatment. Infants are randomized into treatment arms of <96 hrs old and >96 hrs old. Ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5 mg/kg dose and then 24 hours later another dose of 5 mg/kg. An echocardiogram will be done prior to treatment and then within 48 hours after treatment.

Official Title
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Early vs. Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure and Pain/Stress Reduction

Conditions
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Patent Ductus Arteriosus, Prematurity

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Birth weight less than 1200gm Less than 28 weeks gestational age Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam Exclusion Criteria: Active Bleeding Currently being treated for Persistent Pulmonary Hypertension (PPHN) Cardiac anomalies Chromosomal abnormalities Endocrine, metabolic, renal, or hepatic disorders

Ages Eligible for Study
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Maximum Age: 96 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early treatment<br>Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old | Drug: Ibuprofen<br>* Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose<br>* Other names: NeoProfen;|
| Active Comparator: Late treatment<br>Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old. | Drug: Ibuprofen<br>* Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg<br>* Other names: NeoProfen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of PDA Closures Related to Treatment With Ibuprofen | Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant. | Within 48 hrs of ibuprofen round | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration |  | 1 and 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature infants, PDA, ibuprofen