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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

Primary Purpose

Bilirubin Encephalopathy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
usual prescribed intralipid (UL) regimen
restricted prescribed intralipid (RL) regimen
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilirubin Encephalopathy focused on measuring preterm, bilirubin, lipid emulsions, unbound bilirubin, unbound free fatty acids

Eligibility Criteria

undefined - 27 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

usual prescribed intralipid (UL) regimen

restricted prescribed intralipid (RL) regimen

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with unbound bilirubin (UB) concentration greater than 40 nM/L
Average unbound bilirubin (UB) concentration
6 UB measurements will be taken per participant .Average of the 6 readings will be reported
Number of patients with a prolonged brain stem auditory-evoked response (BAER) V latency

Secondary Outcome Measures

Mean UB concentration
Number of patients with UB measurements greater than 40 nM/L
Peak UB concentration
Total unbound free fatty acids (FFA)
6 FFA measurements will be taken for each participant.Average of the 6 readings will be reported
Peak total unbound free fatty acids (FFA)
Peak total serum bilirubin
Number of patients with Direct bilirubin greater than 1.5 mg/dL
Amount of protein given to participant in grams per kilograms per day
Amount of carbohydrates given to participant in grams per kilograms per day
Amount of fats given to participant in grams per kilograms per day
Change in weight(grams/kilogram/day)
Change in weight(grams/kilogram/day)
Number of patients with Bronchopulmonary dysplasia
number of patients with Perinatal and hospital acquired sepsis episodes
Number of patients who died
Number of patients with neurodevelopmental impairment
Number of patients with hearing loss
Number of patients with cerebral palsy

Full Information

First Posted
October 6, 2020
Last Updated
August 2, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT04584983
Brief Title
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
Official Title
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilirubin Encephalopathy
Keywords
preterm, bilirubin, lipid emulsions, unbound bilirubin, unbound free fatty acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
usual prescribed intralipid (UL) regimen
Arm Type
Active Comparator
Arm Title
restricted prescribed intralipid (RL) regimen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
usual prescribed intralipid (UL) regimen
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
restricted prescribed intralipid (RL) regimen
Intervention Description
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 Outcome Measure Information:
Title
Number of patients with unbound bilirubin (UB) concentration greater than 40 nM/L
Time Frame
within first 14 days of life
Title
Average unbound bilirubin (UB) concentration
Description
6 UB measurements will be taken per participant .Average of the 6 readings will be reported
Time Frame
within first 14 days of life
Title
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 Measure Information:
Title
Mean UB concentration
Time Frame
within first 14 days of life
Title
Number of patients with UB measurements greater than 40 nM/L
Time Frame
within first 14 days of life
Title
Peak UB concentration
Time Frame
within first 14 days of life
Title
Total unbound free fatty acids (FFA)
Description
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
Title
Peak total unbound free fatty acids (FFA)
Time Frame
within first 14 days of life
Title
Peak total serum bilirubin
Time Frame
within first 14 days of life
Title
Number of patients with Direct bilirubin greater than 1.5 mg/dL
Time Frame
Before discharge (discharge is on average 3 months after birth)
Title
Amount of protein given to participant in grams per kilograms per day
Time Frame
within first 14 days of life
Title
Amount of carbohydrates given to participant in grams per kilograms per day
Time Frame
within first 14 days of life
Title
Amount of fats given to participant in grams per kilograms per day
Time Frame
within first 14 days of life
Title
Change in weight(grams/kilogram/day)
Time Frame
birth,day 28
Title
Change in weight(grams/kilogram/day)
Time Frame
birth,post menstrual age 36 weeks
Title
Number of patients with Bronchopulmonary dysplasia
Time Frame
36 weeks post menstrual age
Title
number of patients with Perinatal and hospital acquired sepsis episodes
Time Frame
birth until discharge ( discharge will be about 3 months post birth)
Title
Number of patients who died
Time Frame
24 months PMA
Title
Number of patients with neurodevelopmental impairment
Time Frame
24 months PMA
Title
Number of patients with hearing loss
Time Frame
24 months PMA
Title
Number of patients with cerebral palsy
Time Frame
24 months PMA

10. Eligibility

Sex
All
Maximum Age & Unit of Time
27 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay F Holzapfel, MD, MS
Phone
(713) 500-6422
Email
Lindsay.N.Fleig@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily K Stephens
Phone
(713) 500-5734
Email
Emily.K.Stephens@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay F Holzapfel, MD, MS
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay F Holzapfel, MD, MS
Phone
713-500-6422
Email
Lindsay.N.Fleig@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Emily Stephens
Phone
(713) 500-5734
Email
Emily.K.Stephens@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
37430233
Citation
Holzapfel LF, Arnold C, Tyson JE, Shapiro SM, Reynolds EW, Pedroza C, Stephens EK, Kleinfeld A, Huber AH, Rysavy MA, Del Mar Romero Lopez M, Khan AM. Effect of reduced versus usual lipid emulsion dosing on bilirubin neurotoxicity and neurodevelopmental impairment in extremely preterm infants: study protocol for a randomized controlled trial. BMC Pediatr. 2023 Jul 10;23(1):347. doi: 10.1186/s12887-023-04149-0.
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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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