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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice
Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice).
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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
6 UB measurements will be taken per participant .Average of the 6 readings will be reported
Time frame: within first 14 days of life
Brain Stem Auditory-evoked Response (BAER) V Latency
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.
Time frame: 38 weeks post menstrual age(PMA)
Peak Free Fatty Acid Uptake (FFAU)
Time frame: within first 14 days of life
Peak UB Concentration
Time frame: within first 14 days of life
Total Unbound Free Fatty Acids (FFA)
6 FFA measurements will be taken for each participant.Average of the 6 readings will be reported
Time frame: within first 14 days of life
Peak Total Serum Bilirubin
Time frame: within first 14 days of life
Number of Patients With Direct Bilirubin Greater Than 1.5 mg/dL
Time frame: Before discharge (discharge is on average 3 months after birth)
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Amount of Protein Given to Participant in Grams Per Kilograms on Day 14 of Life
Calculated as the mean daily protein intake in grams per kilogram of body weight on Day 14 of life.
Time frame: Day 14 of life
Amount of Carbohydrates Given to Participant in Grams Per Kilograms on Day 14 of Life
Calculated as the mean daily carbohydrates intake in grams per kilogram of body weight on Day 14 of life.
Time frame: Day 14 of life
Amount of Fats Given to Participant in Grams Per Kilograms on Day 14 of Life
Calculated as the mean daily fats intake in grams per kilogram of body weight on Day 14 of life.
Time frame: Day 14 of Life
Weight z Score
Weight Z-scores were calculated using the PediTools Fenton Growth Curves Calculator (2013 version), based on the Fenton Preterm Growth Charts. The following thresholds were used for interpretation: Z-score ≤ -2: Growth failure (worse outcome) Z-score = 0: Population mean (appropriate outcome) Z-score 0 to \<2: Appropriate growth (better outcome) Z-score ≥ 2: Excessive growth (worse outcome)
Time frame: day 28
Weight
Time frame: birth
Weight
Time frame: 36 weeks postmenstrual age
Number of Patients With Bronchopulmonary Dysplasia
Time frame: 36 weeks post menstrual age
Number of Patients With Perinatal and Hospital Acquired Sepsis Episodes
Time frame: birth until discharge ( discharge will be about 3 months post birth)
Number of Patients Who Died
Time frame: 24 months PMA
Number of Patients With Neurodevelopmental Impairment
Time frame: 24 months PMA
Number of Patients With Hearing Loss
Time frame: 24 months PMA
Number of Patients With Cerebral Palsy
Time frame: 24 months PMA
Serial FiO2 (Fraction of Inspired Oxygen)
Time frame: Day 1 of life through day 14 of life
Ventilator Setting
Time frame: Day 1 of life through day 14 of life