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

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ClinicalTrials.gov Identifier: NCT04584983
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Lindsay Fleig Holzapfel, MD, The University of Texas Health Science Center, Houston

Study Description
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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 Potentials, and neurodevelopmental Outcome at 2 Years in Extremely Preterm Infants

Condition or disease Intervention/treatment Phase
Bilirubin Encephalopathy Drug: usual prescribed intralipid (UL) regimen Drug: restricted prescribed intralipid (RL) regimen Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
Actual Study Start Date : January 6, 2021
Estimated Primary Completion Date : January 6, 2023
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: usual prescribed intralipid (UL) regimen Drug: usual prescribed intralipid (UL) regimen
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
Experimental: restricted prescribed intralipid (RL) regimen Drug: restricted prescribed intralipid (RL) regimen
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).


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with unbound bilirubin (UB) concentration greater than 40 nM/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. Number of patients with a prolonged brain stem auditory-evoked response (BAER) V latency [ Time Frame: 34-36 weeks post menstrual age(PMA) ]

Secondary Outcome Measures :
  1. Mean UB concentration [ Time Frame: within first 14 days of life ]
  2. Number of patients with UB measurements greater than 40 nM/L [ Time Frame: within first 14 days of life ]
  3. Peak UB concentration [ Time Frame: within first 14 days of life ]
  4. 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

  5. Peak total unbound free fatty acids (FFA) [ Time Frame: within first 14 days of life ]
  6. Peak total serum bilirubin [ Time Frame: within first 14 days of life ]
  7. Number of patients with Direct bilirubin greater than 1.5 mg/dL [ Time Frame: Before discharge (discharge is on average 3 months after birth) ]
  8. Amount of protein given to participant in grams per kilograms per day [ Time Frame: within first 14 days of life ]
  9. Amount of carbohydrates given to participant in grams per kilograms per day [ Time Frame: within first 14 days of life ]
  10. Amount of fats given to participant in grams per kilograms per day [ Time Frame: within first 14 days of life ]
  11. Change in weight(grams/kilogram/day) [ Time Frame: birth,day 28 ]
  12. Change in weight(grams/kilogram/day) [ Time Frame: birth,post menstrual age 36 weeks ]
  13. Number of patients with Bronchopulmonary dysplasia [ Time Frame: 36 weeks post menstrual age ]
  14. number of patients with Perinatal and hospital acquired sepsis episodes [ Time Frame: birth until discharge ( discharge will be about 3 months post birth) ]
  15. Number of patients who died [ Time Frame: 24 months PMA ]
  16. Number of patients with neurodevelopmental impairment [ Time Frame: 24 months PMA ]
  17. Number of patients with hearing loss [ Time Frame: 24 months PMA ]
  18. Number of patients with cerebral palsy [ Time Frame: 24 months PMA ]

Eligibility Criteria
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Ages Eligible for Study:   up to 27 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584983


Contacts
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Contact: Lindsay N Fleig, MD (713) 500-6422 Lindsay.N.Fleig@uth.tmc.edu
Contact: Emily K Stephens (713) 500-5734 Emily.K.Stephens@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Lindsay N Fleig, MD    713-500-6422    Lindsay.N.Fleig@uth.tmc.edu   
Contact: Emily Stephens    (713) 500-5734    Emily.K.Stephens@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Lindsay N Fleig, MD The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Lindsay Fleig Holzapfel, MD, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04584983    
Other Study ID Numbers: HSC-MS-20-0916
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lindsay Fleig Holzapfel, MD, The University of Texas Health Science Center, Houston:
preterm
bilirubin
lipid emulsions
unbound bilirubin
unbound free fatty acids
Additional relevant MeSH terms:
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Brain Diseases
Neurotoxicity Syndromes
Kernicterus
Central Nervous System Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Brain Diseases, Metabolic
Erythroblastosis, Fetal
Hematologic Diseases
 Infant, Newborn, Diseases
Metabolic Diseases
Immune System Diseases
Hyperbilirubinemia
Pathologic Processes
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions