NCT01758913

Brief Summary

Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been used for years. Previous studies indicated that ibuprofen has similar effect on ductal closure as indomethacin but has less adverse effects on renal function, cerebral blood flow and mesenteric blood flow.1-7 There are, however, very few studies being done specifically on extremely low birth weight (ELBW) infant \< 1000 g. This group of infants has immature kidney and often has poor response to PG inhibitors and has high mortality and morbidity. We hypothesized that, in ELBW infants, the ductal and renal response to PG inhibitors may be different between indomethacin and ibuprofen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

5 years

First QC Date

December 16, 2012

Last Update Submit

January 1, 2013

Conditions

Patent Ductus Arteriosus

Keywords

Bronchopulmonary dysplasiapatent ductus arteriosusprostaglandinRespiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of infants with ductus closure

    To compare the number of infants with ductus closure treated with indomethacin and ibuprofen in extremely low birth weight infants.

    6 months

Secondary Outcomes (1)

  • Urine output

    1 month

Other Outcomes (1)

  • Serum creatinine

    1 month

Study Arms (1)

Ibuprofen

EXPERIMENTAL

Infant who was assigned to ibuprofen, an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 hours respectively as a course was given.

Drug: Ibuprofen

Interventions

IbuprofenDRUG

To compare the efficacy, the side effects and the renal prostaglandin (PG) excretion between indomethacin and ibuprofen in extremely low birth weight (ELBW) infants.

Also known as: 2-[4-(2-methylpropyl)phenyl]propanoic acid
Ibuprofen

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The selection criteria were: (1) preterm infants with birth weight \<1000 g; 2) radiographic diagnosis of respiratory distress syndrome (RDS); (3) requirement of mechanical ventilation and (4) echocardiographic and clinical evidence of significant patent ductus arteriosus (PDA).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • Yeh TF, Achanti B, Patel H, Pildes RS. Indomethacin therapy in premature infants with patent ductus arteriosus--determination of therapeutic plasma levels. Dev Pharmacol Ther. 1989;12(4):169-78.

    PMID: 2766920BACKGROUND

  • Yeh TF, Raval D, Luken J, Thalji A, Lilien L, Pildes RS. Clinical evaluation of premature infants with patent ductus arteriosus: a scoring system with echocardiogram, acid-base, and blood gas correlations. Crit Care Med. 1981 Sep;9(9):655-7. doi: 10.1097/00003246-198109000-00009.

    PMID: 7273813BACKGROUND

  • Yeh TF, Luken J, Raval D, Thalji A, Carr I, Pildes RS. Indomethacin treatment in small versus large premature infants with ductus arteriosus. Comparison of plasma indomethacin concentration and clinical response. Br Heart J. 1983 Jul;50(1):27-30. doi: 10.1136/hrt.50.1.27.

    PMID: 6860508BACKGROUND

MeSH Terms

Conditions

Ductus Arteriosus, PatentBronchopulmonary DysplasiaRespiratory Distress Syndrome

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVentilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Tsu-Fu Yeh, MD, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2012

First Posted

January 1, 2013

Study Start

February 1, 2007

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations

US(1)