NCT03008876

Brief Summary

This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

December 30, 2016

Last Update Submit

July 5, 2019

Conditions

Patent Ductus Arteriosus

Keywords

neonateacetaminophen

Outcome Measures

Primary Outcomes (1)

  • Rate of PDA Closure

    PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.

    3 days

Secondary Outcomes (1)

  • Change in PDA size

    3 days

Study Arms (2)

acetaminophen

EXPERIMENTAL

Group of patients randomized to receive acetaminophen to treat their PDA

Drug: Acetaminophen

ibuprofen

ACTIVE COMPARATOR

Group of patients randomized to receive ibuprofen to treat their PDA

Drug: Ibuprofen

Interventions

AcetaminophenDRUG

infants receive acetaminophen for treatment of their PDA

Also known as: tylenol
acetaminophen
IbuprofenDRUG

infants receive ibuprofen, standard of care in our unit, for treatment of a PDA

ibuprofen

Eligibility Criteria

Age1 Minute - 2 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • preterm infants 23-30 weeks gestation,
  • PDA requiring treatment

You may not qualify if:

  • infection,
  • congenital heart disease,
  • genetic syndrome,
  • NEC,
  • pulmonary hypertension,
  • hydrops,
  • intestinal perforation,
  • grade 3 or 4 IVH,
  • serum creatinine \>1.5,
  • previous treatment with a COX inhibitor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical Center Neonatal Intesive Care Unit

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 30, 2016

First Posted

January 4, 2017

Study Start

January 1, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)