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Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure

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ClinicalTrials.gov Identifier: NCT00833365
Recruitment Status : Terminated (Study drug not available)
First Posted : February 2, 2009
Results First Posted : July 4, 2016
Last Update Posted : July 4, 2016
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Patent Ductus Arteriosus
Prematurity
Intervention Drug: Ibuprofen
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early Treatment Late Treatment
Hide Arm/Group Description

Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old

Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose

Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.

Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Period Title: Overall Study
Started 9 6
Completed 9 6
Not Completed 0 0
Arm/Group Title Early Treatment Late Treatment Total
Hide Arm/Group Description

Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old

Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose

Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.

Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Total of all reporting groups
Overall Number of Baseline Participants 9 6 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
<=18 years
9
 100.0%
6
 100.0%
15
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Female
6
  66.7%
2
  33.3%
8
  53.3%
Male
3
  33.3%
4
  66.7%
7
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 6 participants 15 participants
9 6 15
1.Primary Outcome
Title Number of PDA Closures Related to Treatment With Ibuprofen
Hide Description Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant.
Time Frame Within 48 hrs of ibuprofen round
Hide Outcome Measure Data
Hide Analysis Population Description
Premature infants born at 23+3 weeks to 29+4 weeks with positive patent ductus arteriosus on cardiac echogram were randomized to early or late treatment with ibuprofen. 2 babies which had been originally randomized to the late treatment arm never got ibuprofen and are not included in analysis.
Arm/Group Title Early Treatment Late Treatment
Hide Arm/Group Description:

Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old

Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose

Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.

Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Overall Number of Participants Analyzed 9 4
Measure Type: Number
Unit of Measure: closures related to treatment
1 0
2.Secondary Outcome
Title Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration
Hide Description [Not Specified]
Time Frame 1 and 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, labs were not analyzed.
Arm/Group Title Early Treatment Late Treatment
Hide Arm/Group Description:

Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old

Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose

Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.

Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Early Treatment Late Treatment
Hide Arm/Group Description

Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old

Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose

Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.

Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg

All-Cause Mortality
Early Treatment Late Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Early Treatment Late Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   1/9 (11.11%)   0/6 (0.00%) 
Infections and infestations     
Death  [1]  1/9 (11.11%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Infant died from necrotizing enterocolitis, an abdominal infection not unexpected in the premature infant population.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Early Treatment Late Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gary Chan
Organization: University of Utah
Phone: 801-587-7508
EMail: gary.chan@hsc.utah.edu
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00833365     History of Changes
Other Study ID Numbers: 31394
First Submitted: January 29, 2009
First Posted: February 2, 2009
Results First Submitted: May 1, 2015
Results First Posted: July 4, 2016
Last Update Posted: July 4, 2016