Patent Ductus Arteriosus, Prematurity
Conditions
Keywords
premature infants, PDA, ibuprofen
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.
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.
Interventions
DRUGIbuprofen
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
Sponsors
H. Lundbeck A/S
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 96 Hours
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration | 1 and 6 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| 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 | 6 |
| Total | 15 |
Baseline characteristics
| Characteristic | Early Treatment | Late Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 6 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 9 participants | 6 participants | 15 participants |
| Sex: Female, Male Female | 6 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 6 |
| serious Total, serious adverse events | 1 / 9 | 0 / 6 |
Outcome results
Primary
Number of PDA Closures Related to Treatment With Ibuprofen
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Treatment | Number of PDA Closures Related to Treatment With Ibuprofen | 1 closures related to treatment |
| Late Treatment | Number of PDA Closures Related to Treatment With Ibuprofen | 0 closures related to treatment |
Secondary
Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration
Time frame: 1 and 6 hours
Population: Due to early termination of the study, labs were not analyzed.