Alternative Paracetamol Treatments for the Neonate With a hsPDA

Alternative Acetaminophen Treatment of the Hemodynamivally Significant Patent Ductus Arteriosus in Preterm Neonates Who Are Not Candidates for Enteral Administration: A Pilot Study

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03604796

Enrollment

Registered

2018-07-30

Start date

2018-09-30

Completion date

2022-01-31

Last updated

2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ductus Arteriosus, Patent

Keywords

acetaminophen

Brief summary

Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended. Our standard first line therapeutic approach is enteral acetaminophen. However many extremely low birth weight infants may be on limited or no feeds when PDA closure is determined to be indicated, thus restricting the use of enteral acetaminophen. Several studies have suggested that intravenous acetaminophen is less effective than enteral. Thus, in this study, we propose to compare two alternative modes of administration when enteral acetaminophen is not an option.

Detailed description

Once parental consent for entrance into the study is obtained, eligible babies will be randomized to receive either IV acetaminophen (perfalgen) by continuous infusion at 2.5 mg/kg/h following a loading dose of 15 mg /kg/ over 20 minutes or rectal acetaminophen at 15 mg/kg every 6 hours for a period of 3 days.

Interventions

DRUGIntravenous Infusion

Loading dose of 15 mg/kg IV acetaminophen followed by a continuous infusion at a rate of 2.5 mg/kg/hr for 72 hours

DRUGRectal Solution

Rectal acetaminophen at 15 mg/kg x 4/day for three days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Days to 10 Days

Healthy volunteers

Inclusion criteria

Inborn preterm neonates, \< 1000 gm birth weight; \< 28 weeks' gestational age; who are admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and are diagnosed with a hemodynamically significant patent ductus arteriosus within the first week of life and who are on limited or no enteral feeds -

Exclusion criteria

Other congenital heart disease, major congenital anomalies, sepsis; and/or NEC.

Design outcomes

Primary

Measure	Time frame	Description
Ductal closure	Up to 1 week following treatment	Follow-up echocardiogram showing closed ductus arteriosus

Secondary

Measure	Time frame	Description
PDA Ligation	Completion of study intervention until 40 weeks post-conception	Need for surgical ligation

Countries

Israel

Contacts

Primary ContactCathy Hammerman, MD

cathyh@ekmd.huji.ac.il0508685238

Backup ContactAlona Bin-Nun, MD

alonabinnun@szmc.org.il0508685757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026