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

Bilirubin Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04584983
• Other study ID #: HSC-MS-20-0916
• Secondary ID: KL2TR003168
• Status: Recruiting
• Phase: Phase 2
• Start date: January 6, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Lindsay F Holzapfel, MD, MS
• Phone: (713) 500-6422
• Email: Lindsay.N.Fleig[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 27 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bilirubin Encephalopathy
• Brain Diseases
• Kernicterus
• Neurotoxicity Syndromes

Intervention

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
• 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).

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with unbound bilirubin (UB) concentration greater than 40 nM/L		within first 14 days of life
Primary	Average unbound bilirubin (UB) concentration	6 UB measurements will be taken per participant .Average of the 6 readings will be reported	within first 14 days of life
Primary	Number of patients with a prolonged brain stem auditory-evoked response (BAER) V latency		34-36 weeks post menstrual age(PMA)
Secondary	Mean UB concentration		within first 14 days of life
Secondary	Number of patients with UB measurements greater than 40 nM/L		within first 14 days of life
Secondary	Peak UB concentration		within first 14 days of life
Secondary	Total unbound free fatty acids (FFA)	6 FFA measurements will be taken for each participant.Average of the 6 readings will be reported	within first 14 days of life
Secondary	Peak total unbound free fatty acids (FFA)		within first 14 days of life
Secondary	Peak total serum bilirubin		within first 14 days of life
Secondary	Number of patients with Direct bilirubin greater than 1.5 mg/dL		Before discharge (discharge is on average 3 months after birth)
Secondary	Amount of protein given to participant in grams per kilograms per day		within first 14 days of life
Secondary	Amount of carbohydrates given to participant in grams per kilograms per day		within first 14 days of life
Secondary	Amount of fats given to participant in grams per kilograms per day		within first 14 days of life
Secondary	Change in weight(grams/kilogram/day)		birth,day 28
Secondary	Change in weight(grams/kilogram/day)		birth,post menstrual age 36 weeks
Secondary	Number of patients with Bronchopulmonary dysplasia		36 weeks post menstrual age
Secondary	number of patients with Perinatal and hospital acquired sepsis episodes		birth until discharge ( discharge will be about 3 months post birth)
Secondary	Number of patients who died		24 months PMA
Secondary	Number of patients with neurodevelopmental impairment		24 months PMA
Secondary	Number of patients with hearing loss		24 months PMA
Secondary	Number of patients with cerebral palsy		24 months PMA