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Completed

NCT Number: NCT01755728

Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

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.

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Key information

Conditions

PDA

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neonatal intensive care unit, Hillel Yaffe medical center

Hadera, 38100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Paracetamol

Drug

Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.

Other names: Acetaminophen

Ibuprofen

Drug

Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature

Closure of PDA

Procedure

Open surgery for closure of PDA

Primary outcomes

  1. Closure of arterial duct - yes / No

    Time frame: 1 week

    Echo-cardiogram that will give exact answer to the question: "was the arterial duct closed"?

Secondary outcomes

  1. Need for surgical closure of arterial duct

    Time frame: 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

Other outcomes

  1. Death or deterioration

    Time frame: 1 week

    The infant state deteriorates so quickly that it will die, either because of complication of the arterial duct, or because other causes, such as sepsis, metabolic disorder, etc...

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 24, 2012
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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