Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

Hillel Yaffe Medical Center

Status and phase

Completed

Phase 3

Conditions

PDA

Treatments

Drug: Paracetamol

Drug: Ibuprofen

Procedure: Closure of PDA

Study type

Interventional

Funder types

Other

Identifiers

NCT01755728

77-12-HYMC-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

Under 4 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

None

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 5 patient groups

No known PDA

No Intervention group

Description:

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.

Ibuprofen

Active Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen

Surgical closure of PDA

Active Comparator group

Description:

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.

Treatment:

Procedure: Closure of PDA

Paracetamol

Experimental group

Description:

Infants with symptomatic PDA who could not be treated with ibuprofen, and their parents agreed and they could be treated with paracetamol.

Treatment:

Drug: Paracetamol

DA closed spontaneously

No Intervention group

Description:

Infants with PDA, who did not get any treatment for it, and the duct was closed spontaneously.