Alternative Paracetamol Treatments for the Neonate With a hsPDA

NCT03604796 | Unknown Phase 2

• 1 other identifier: 0207-18-SZMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ductus Arteriosus, Patent

Keywords

acetaminophen

Outcome Measures

Primary Outcomes (1)

• Ductal closure

  Follow-up echocardiogram showing closed ductus arteriosus

  Up to 1 week following treatment

Secondary Outcomes (1)

• PDA Ligation

  Completion of study intervention until 40 weeks post-conception

Study Arms (2)

Continuous IV Acetaminophen

ACTIVE COMPARATOR

Intravenous Infusion

Drug: Intravenous Infusion

Rectal Acetaminophen

ACTIVE COMPARATOR

Rectal Solution

Drug: Rectal Solution

Interventions

Rectal Solution DRUG

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

Also known as: acetaminophen / paracetamol

Rectal Acetaminophen

Intravenous Infusion DRUG

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

Also known as: acetaminophen / paracetamol

Continuous IV Acetaminophen

Eligibility Criteria

• Age: 2 Days - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 -

You may not qualify if:

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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Neonatal Intensive Care Unit - Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Acetaminophen; Infusions, Intravenous

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Cathy Hammerman, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Hammerman, MD

CONTACT

0508685238; cathyh@ekmd.huji.ac.il

Alona Bin-Nun, MD

CONTACT

0508685757; alonabinnun@szmc.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 30, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: January 1, 2022
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)