Trial Outcomes & Findings for Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure (NCT NCT00833365)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Within 48 hrs of ibuprofen round

Results posted on

2016-07-04

Participant Flow

Participant milestones

Participant milestones
Measure	Early Treatment 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	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. Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg
Overall Study STARTED	9	6
Overall Study COMPLETED	9	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Treatment n=9 Participants 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	Late Treatment n=6 Participants 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 n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 48 hrs of ibuprofen round

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Early Treatment n=9 Participants 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	Late Treatment n=4 Participants 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
Number of PDA Closures Related to Treatment With Ibuprofen	1 closures related to treatment	0 closures related to treatment

SECONDARY outcome

Timeframe: 1 and 6 hours

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

Outcome measures

Outcome data not reported

Adverse Events

Early Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Late Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Early Treatment n=9 participants at risk 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	Late Treatment n=6 participants at risk 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
Infections and infestations Death	11.1% 1/9	0.00% 0/6

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gary Chan

University of Utah

Phone: 801-587-7508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place