drugset / Trial / NCT04584983
Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
Phase 2
Active not recruiting
134 enrolled
The University of Texas Health Science Center, Houston
National Center for Advancing Translational Sciences (NCATS) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-02-11
- Primary completion
- 2024-03-14
- Completion
- 2026-06-14
Publications
- Background 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.
- Holzapfel L, Arnold C, Tyson J, Shapiro S, Reynolds E, Pedroza C, Stephens E, Kleinfeld A, Huber A, Rysavy M, Khan A, Del Mar Romero Lopez M. 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. Res Sq [Preprint]. 2023 Mar 7:rs.3.rs-2566352. doi: 10.21203/rs.3.rs-2566352/v1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Intralipid | Other / unclassified | 1.5 g/kg | Intravenous |
| Comparator | Intralipid | Other / unclassified | 3 g/kg | Intravenous |