Active — Not RecruitingPhase 2

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

United States134 participantsStarted 2021-02-11

Plain-language 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.

Who can participate

Age range27 Weeks

SexALL

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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

What they're measuring

Number of Patients With Unbound Bilirubin (UB) Concentration Greater Than 30 Nanomoles Per Liter (Nmol/L)

Timeframe: within first 14 days of life

Average Unbound Bilirubin (UB) Concentration

Timeframe: within first 14 days of life

Brain Stem Auditory-evoked Response (BAER) V Latency

Timeframe: 38 weeks post menstrual age(PMA)

Trial details

NCT IDNCT04584983

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-14

Results submitted2025-05-31

View on ClinicalTrials.gov More Bilirubin Encephalopathy trials