Alternative Paracetamol Treatments for the Neonate With a hsPDA

Shaare Zedek Medical Center

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Ductus Arteriosus, Patent

Treatments: Drug: Intravenous Infusion; Drug: Rectal Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03604796

0207-18-SZMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 10 days old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Continuous IV Acetaminophen

Active Comparator group

Description:

Intravenous Infusion

Treatment:

Drug: Intravenous Infusion

Rectal Acetaminophen

Active Comparator group

Description:

Rectal Solution

Treatment:

Drug: Rectal Solution