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

• Sponsor: University of Utah (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00833365
• Collaborator: H. Lundbeck A/S (Industry)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus; Prematurity	Drug: Ibuprofen; Drug: Ibuprofen	N/A

Detailed Description

Infants with birth weight at <1200gm and/or <28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to treatment. Infants are randomized into treatment arms of <96 hrs old and >96 hrs old. Ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5 mg/kg dose and then 24 hours later another dose of 5 mg/kg. An echocardiogram will be done prior to treatment and then within 48 hours after treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early vs. Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure and Pain/Stress Reduction
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Early treatment Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old	Drug: 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; Other Names: NeoProfen
Active Comparator: Late treatment 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.	Drug: Ibuprofen; Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg; Other Names: NeoProfen

Outcome Measures

Primary Outcome Measures

1. Number of PDA Closures Related to Treatment With Ibuprofen [Within 48 hrs of ibuprofen round]

   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.

Secondary Outcome Measures

1. Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration [1 and 6 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 96 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Birth weight less than 1200gm

• Less than 28 weeks gestational age

• Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam

Exclusion Criteria:

• Active Bleeding

• Currently being treated for Persistent Pulmonary Hypertension (PPHN)

• Cardiac anomalies

• Chromosomal abnormalities

• Endocrine, metabolic, renal, or hepatic disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• University of Utah
• H. Lundbeck A/S

Investigators

• Principal Investigator: Gary Chan, MD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Utah
• ClinicalTrials.gov Identifier: NCT00833365
• Other Study ID Numbers: 31394
• First Posted: Feb 2, 2009
• Last Update Posted: Jul 4, 2016
• Last Verified: Dec 1, 2014

• Keywords provided by University of Utah: premature infants; PDA; ibuprofen
• Additional relevant MeSH terms: Ductus Arteriosus, Patent; Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Early Treatment	Late Treatment
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

Baseline Characteristics

Arm/Group Title	Early Treatment	Late Treatment	Total
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 Participants	9	6	15
Age (Count of Participants)
<=18 years	9 100%	6 100%	15 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	6 66.7%	2 33.3%	8 53.3%
Male	3 33.3%	4 66.7%	7 46.7%
Region of Enrollment (participants) [Number]
United States	9 100%	6 100%	15 100%

Outcome Measures

1. Primary Outcome

Title	Number of PDA Closures Related to Treatment With Ibuprofen
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

Outcome Measure Data

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
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
Measure Participants	9	4
Number [closures related to treatment]	1	0

2. Secondary Outcome

Title	Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration
Time Frame	1 and 6 hours

Outcome Measure Data

Analysis Population Description

Due to early termination of the study, labs were not analyzed.

Arm/Group Title	Early Treatment	Late Treatment
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
Measure Participants	0	0

Adverse Events

Arm/Group Title	Early Treatment		Late Treatment
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Early Treatment		Late Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		0/6 (0%)
Infections and infestations
Death	1/9 (11.1%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Early Treatment		Late Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.