Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

Conditions
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PDA

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Ibuprofen
* Procedure: Closure of PDA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants with symptomatic PDA who could not be treated with ibuprofen Exclusion Criteria: None

Ages Eligible for Study
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Maximum Age: 4 Months

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No known PDA<br>For all infants, we do echo cardiogram study only if they are suspected of having PDA, due to sings and symptoms. Hence, we do not do echo cardiogram study to most of the infants. | |
| Active Comparator: Ibuprofen<br>If there is a PDA, that should be treated, and the infant is less than 2 weeks of age, we use ibuprofen, as this is the gold standard in literature. | Drug: Ibuprofen<br>* Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature<br>|
| Active Comparator: Surgical closure of PDA<br>Infants with symptomatic PDA, who had to be treated, but could not be treated by ibuprofen, either due to age (> 2 weeks) or due ibuprofen contraindications (thrombocytopenia or renal failure), whose could not be treated by paracetamol (either because of parents' refuse or because they were on nothing per os protocol due to other disease), for whom surgery was the treatment of choice to close the arterial duct. | Procedure: Closure of PDA<br>* Open surgery for closure of PDA<br>|
| Experimental: Paracetamol<br>Infants with symptomatic PDA who could not be treated with ibuprofen, and their parents agreed and they could be treated with paracetamol. | Drug: Paracetamol<br>* Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.<br>* Other names: Acetaminophen;|
| No Intervention: DA closed spontaneously<br>Infants with PDA, who did not get any treatment for it, and the duct was closed spontaneously. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of arterial duct - yes / No | Echo-cardiogram that will give exact answer to the question: was the arterial duct closed? | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for surgical closure of arterial duct | The clinical state of the infant will guide the team to ask the parents and the chest surgeon to surgically close the arterial duct | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paracetamol, Acetaminophen, PDA, Preterm infants