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Bilirubin Neurotoxicity (BN) and Neurodevelopmental Impairment (NDI) in Extremely Preterm (EP) Infants: Avoidable by Reducing the Usual Intravenous Lipid (UL) Administration
Phase 2 trial testing usual prescribed intralipid (UL) regimen in Bilirubin Encephalopathy in 134 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 134 |
| Start date | 11 February 2021 |
| Primary completion | 14 March 2024 |
| Estimated completion | 14 June 2026 |
| Sites | 1 location across United States |
The University of Texas Health Science Center, Houston
Under 27 Weeks, any sex, with Bilirubin Encephalopathy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 2 | |
| Restricted Prescribed Intralipid (RL) Regimen | 3 |
6 UB measurements will be taken per participant .Average of the 6 readings will be reported
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 12.3 | ± 7.8 |
| Restricted Prescribed Intralipid (RL) Regimen | 13.2 | ± 7.8 |
Brainstem auditory evoked response (BAER) testing is a procedure used to assess the auditory pathways of the brainstem and evaluate hearing ability. Wave latency, measured in milliseconds, is the measure of electric transmission of sound. If the wave latency is prolonged, this means that something is in the way of electric sound wave transmission, such as bilirubin which has an affinity for depositing in a specific area of the brainstem that wave V measures.
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 7.25 | ± 0.58 |
| Restricted Prescribed Intralipid (RL) Regimen | 7.34 | ± 0.48 |
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 105.53 | ± 92.76 |
| Restricted Prescribed Intralipid (RL) Regimen | 64.39 | ± 81.84 |
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 23.4 | ± 17.5 |
| Restricted Prescribed Intralipid (RL) Regimen | 22.0 | ± 17.7 |
6 FFA measurements will be taken for each participant.Average of the 6 readings will be reported
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 41.4 | ± 27.6 |
| Restricted Prescribed Intralipid (RL) Regimen | 31.0 | ± 34.2 |
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 5 | ± 1.8 |
| Restricted Prescribed Intralipid (RL) Regimen | 5.2 | ± 1.3 |
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 9 | |
| Restricted Prescribed Intralipid (RL) Regimen | 10 |
Calculated as the mean daily protein intake in grams per kilogram of body weight on Day 14 of life.
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 3.62 | ± 0.56 |
| Restricted Prescribed Intralipid (RL) Regimen | 3.60 | ± 0.48 |
Calculated as the mean daily carbohydrates intake in grams per kilogram of body weight on Day 14 of life.
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 13.46 | ± 3.53 |
| Restricted Prescribed Intralipid (RL) Regimen | 13.50 | ± 2.74 |
Calculated as the mean daily fats intake in grams per kilogram of body weight on Day 14 of life.
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | 4.05 | ± 1.39 |
| Restricted Prescribed Intralipid (RL) Regimen | 3.74 | ± 1.68 |
Weight Z-scores were calculated using the PediTools Fenton Growth Curves Calculator (2013 version), based on the Fenton Preterm Growth Charts. The following thresholds were used for interpretation: Z-score ≤ -2: Growth failure (worse outcome) Z-score = 0: Population mean (appropriate outcome) Z-score 0 to \<2: Appropriate growth (better outcome) Z-score ≥ 2: Excessive growth (worse outcome)
| Group | Value | 95% CI |
|---|---|---|
| Usual Prescribed Intralipid (UL) Regimen | -1.019 | ± 0.87 |
| Restricted Prescribed Intralipid (RL) Regimen | -0.870 | ± 0.72 |
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.
No peer-reviewed publications indexed yet for this trial.
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