Clinical trial NCT04584983: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Bilirubin Encephalopathy
Keywords: preterm
bilirubin
lipid emulsions
unbound bilirubin
unbound free fatty acids
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-10-14
Enrollment: 134
Sex: ALL
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of patients with unbound bilirubin (UB) concentration greater than 40 nM/L
timeFrame: within first 14 days of life
measure: Average unbound bilirubin (UB) concentration
timeFrame: within first 14 days of life
measure: Number of patients with a prolonged brain stem auditory-evoked response (BAER) V latency
timeFrame: 34-36 weeks post menstrual age(PMA)
Secondary outcomes:
measure: Mean UB concentration
timeFrame: within first 14 days of life
measure: Number of patients with UB measurements greater than 40 nM/L
timeFrame: within first 14 days of life
measure: Peak UB concentration
timeFrame: within first 14 days of life
measure: Total unbound free fatty acids (FFA)
timeFrame: within first 14 days of life
measure: Peak total unbound free fatty acids (FFA)
timeFrame: within first 14 days of life
measure: Peak total serum bilirubin
timeFrame: within first 14 days of life
measure: Number of patients with Direct bilirubin greater than 1.5 mg/dL
timeFrame: Before discharge (discharge is on average 3 months after birth)
measure: Amount of protein given to participant in grams per kilograms per day
timeFrame: within first 14 days of life
measure: Amount of carbohydrates given to participant in grams per kilograms per day
timeFrame: within first 14 days of life
measure: Amount of fats given to participant in grams per kilograms per day
timeFrame: within first 14 days of life
measure: Change in weight(grams/kilogram/day)
timeFrame: birth,day 28
measure: Change in weight(grams/kilogram/day)
timeFrame: birth,post menstrual age 36 weeks
measure: Number of patients with Bronchopulmonary dysplasia
timeFrame: 36 weeks post menstrual age
measure: number of patients with Perinatal and hospital acquired sepsis episodes
timeFrame: birth until discharge ( discharge will be about 3 months post birth)
measure: Number of patients who died
timeFrame: 24 months PMA
measure: Number of patients with neurodevelopmental impairment
timeFrame: 24 months PMA
measure: Number of patients with hearing loss
timeFrame: 24 months PMA
measure: Number of patients with cerebral palsy
timeFrame: 24 months PMA
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lindsay F Holzapfel, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.