Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

Phase 3

Completed

• Conditions: PDA
• Interventions: Procedure: Closure of PDA; Drug: Ibuprofen; Drug: Paracetamol

• Registration Number: NCT01755728
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-12-16
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-24
• Study Start: 2013-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Preterm infants with symptomatic PDA who could not be treated with ibuprofen

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical closure of PDA	Closure of PDA	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.
Ibuprofen	Ibuprofen	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.
Paracetamol	Paracetamol	Infants with symptomatic PDA who could not be treated with ibuprofen, and their parents agreed and they could be treated with paracetamol.

Primary Outcome Measures

Name	Time	Method
Closure of arterial duct - yes / No	1 week	Echo-cardiogram that will give exact answer to the question: "was the arterial duct closed"?

Secondary Outcome Measures

Name	Time	Method
Need for surgical closure of arterial duct	1 week	The clinical state of the infant will guide the team to ask the parents and the chest surgeon to surgically close the arterial duct

Trial Locations

Locations (1)

Neonatal intensive care unit, Hillel Yaffe medical center; 🇮🇱 Hadera, Israel