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Active, Not Recruiting

NCT Number: NCT04584983

Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bilirubin Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Erythroblastosis, Fetal Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hyperbilirubinemia Immune System Diseases Infant, Newborn, Diseases Kernicterus Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 27 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

usual prescribed intralipid (UL) regimen

Drug

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

restricted prescribed intralipid (RL) regimen

Drug

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).

Primary outcomes

  1. Number of Patients With Unbound Bilirubin (UB) Concentration Greater Than 30 Nanomoles Per Liter (Nmol/L)

    Time frame: within first 14 days of life

  2. 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

  3. 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

  1. Peak Free Fatty Acid Uptake (FFAU)

    Time frame: within first 14 days of life

  2. Peak UB Concentration

    Time frame: within first 14 days of life

  3. Total Unbound Free Fatty Acids (FFA)

    Time frame: within first 14 days of life

    6 FFA measurements will be taken for each participant.Average of the 6 readings will be reported

  4. Peak Total Serum Bilirubin

    Time frame: within first 14 days of life

  5. Number of Patients With Direct Bilirubin Greater Than 1.5 mg/dL

    Time frame: Before discharge (discharge is on average 3 months after birth)

  6. Amount of Protein Given to Participant in Grams Per Kilograms on Day 14 of Life

    Time frame: Day 14 of life

    Calculated as the mean daily protein intake in grams per kilogram of body weight on Day 14 of life.

  7. Amount of Carbohydrates Given to Participant in Grams Per Kilograms on Day 14 of Life

    Time frame: Day 14 of life

    Calculated as the mean daily carbohydrates intake in grams per kilogram of body weight on Day 14 of life.

  8. Amount of Fats Given to Participant in Grams Per Kilograms on Day 14 of Life

    Time frame: Day 14 of Life

    Calculated as the mean daily fats intake in grams per kilogram of body weight on Day 14 of life.

  9. Weight z Score

    Time frame: day 28

    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)

  10. Weight

    Time frame: birth

  11. Weight

    Time frame: 36 weeks postmenstrual age

  12. Number of Patients With Bronchopulmonary Dysplasia

    Time frame: 36 weeks post menstrual age

  13. Number of Patients With Perinatal and Hospital Acquired Sepsis Episodes

    Time frame: birth until discharge ( discharge will be about 3 months post birth)

  14. Number of Patients Who Died

    Time frame: 24 months PMA

  15. Number of Patients With Neurodevelopmental Impairment

    Time frame: 24 months PMA

  16. Number of Patients With Hearing Loss

    Time frame: 24 months PMA

  17. Number of Patients With Cerebral Palsy

    Time frame: 24 months PMA

  18. Serial FiO2 (Fraction of Inspired Oxygen)

    Time frame: Day 1 of life through day 14 of life

  19. Ventilator Setting

    Time frame: Day 1 of life through day 14 of life

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Oct 14, 2020
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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