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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Recruiting

CT.gov ID

NCT04584983

Collaborator

(none)

Enrollment

Location

Arms

47.8

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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 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

Study Type:

Interventional

Anticipated 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 :

Jan 6, 2021

Anticipated Primary Completion Date :

Jan 6, 2023

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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).

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

Primary Outcome Measures

Number of patients with unbound bilirubin (UB) concentration greater than 40 nM/L [within first 14 days of life]
Average unbound bilirubin (UB) concentration [within first 14 days of life]
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 [34-36 weeks post menstrual age(PMA)]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 27 Weeks

Sexes Eligible for Study:

All

Accepts 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