Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Number of Patients With Unbound Bilirubin (UB) Concentration Greater Than 30 Nanomoles Per Liter (Nmol/L)
Study Overview
Brief Summary
The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 27 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •no major congenital anomaly or overt nonbacterial infection
- •mother has consented to inclusion of the infant for the Neonatal Research Network (NRN) Cycled Phototherapy Trial
Exclusion Criteria
- •has received Intralipid
Arms & Interventions
usual prescribed intralipid (UL) regimen
Intervention: usual prescribed intralipid (UL) regimen (Drug)
restricted prescribed intralipid (RL) regimen
Intervention: restricted prescribed intralipid (RL) regimen (Drug)
Outcomes
Primary Outcomes
Number of Patients With Unbound Bilirubin (UB) Concentration Greater Than 30 Nanomoles Per Liter (Nmol/L)
Time Frame: within first 14 days of life
Average Unbound Bilirubin (UB) Concentration
Time Frame: within first 14 days of life
6 UB measurements will be taken per participant .Average of the 6 readings will be reported
Brain Stem Auditory-evoked Response (BAER) V Latency
Time Frame: 38 weeks post menstrual age(PMA)
Brainstem auditory evoked response (BAER) testing is a procedure used to assess the auditory pathways of the brainstem and evaluate hearing ability. Wave latency, measured in milliseconds, is the measure of electric transmission of sound. If the wave latency is prolonged, this means that something is in the way of electric sound wave transmission, such as bilirubin which has an affinity for depositing in a specific area of the brainstem that wave V measures.
Secondary Outcomes
- Number of Patients With Neurodevelopmental Impairment(24 months PMA)
- Number of Patients With Hearing Loss(24 months PMA)
- Number of Patients With Cerebral Palsy(24 months PMA)
- Serial FiO2 (Fraction of Inspired Oxygen)(Day 1 of life through day 14 of life)
- Ventilator Setting(Day 1 of life through day 14 of life)
- Peak Total Serum Bilirubin(within first 14 days of life)
- Number of Patients With Bronchopulmonary Dysplasia(36 weeks post menstrual age)
- Number of Patients With Perinatal and Hospital Acquired Sepsis Episodes(birth until discharge ( discharge will be about 3 months post birth))
- Number of Patients Who Died(24 months PMA)
- Peak Free Fatty Acid Uptake (FFAU)(within first 14 days of life)
- Peak UB Concentration(within first 14 days of life)
- Total Unbound Free Fatty Acids (FFA)(within first 14 days of life)
- Number of Patients With Direct Bilirubin Greater Than 1.5 mg/dL(Before discharge (discharge is on average 3 months after birth))
- Amount of Protein Given to Participant in Grams Per Kilograms on Day 14 of Life(Day 14 of life)
- Amount of Carbohydrates Given to Participant in Grams Per Kilograms on Day 14 of Life(Day 14 of life)
- Amount of Fats Given to Participant in Grams Per Kilograms on Day 14 of Life(Day 14 of Life)
- Weight z Score(day 28)
- Weight(36 weeks postmenstrual age)
Investigators
Lindsay Fleig Holzapfel, MD
Assistant Professor
The University of Texas Health Science Center, Houston