Table 2.
Participant timeline
| Time point | Birth | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | Day 11 | Day 12 | Day 13 | Day 14 | Day 21 | Day 28 | 34 weeks PMA | 36 weeks PMA | Discharge | 22–26 Months CGA |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eligibility | x | x | x | ||||||||||||||||||
| Informed Consent | x | x | x | ||||||||||||||||||
| Allocation | x | x | |||||||||||||||||||
| Randomization | x | x | |||||||||||||||||||
| Enrollment | x | x | |||||||||||||||||||
| Intervention | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |||||||
| Nutrition Intake | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | ||
| Weight | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
| Weight, Length, and Head Circumference Z Scores | x | x | x | ||||||||||||||||||
| Blood Samplea | x | x | x | x | x | x | |||||||||||||||
| Clinical Laboratory Datab | x | x | x | x | x | x | |||||||||||||||
| BAER | x | x | x | ||||||||||||||||||
| Neonatal Clinical Outcomes | x | ||||||||||||||||||||
| NDI Follow Up | x |
Brainstem auditory evoked response (BAER), Corrected gestational age (CGA), Neurodevelopmental impairment (NDI), Post-menstrual age (PMA), aBlood sampling is initiated the morning after the maximum lipid dose is started and occurs for 6 consecutive days. From these blood samples, the Kleinfeld laboratory will measure unbound bilirubin, albumin, total and full profile for unbound free fatty acids profile. bThese will be the clinically indicated blood sample measured in the hospital laboratory including, total serum bilirubin, indirect bilirubin, direct bilirubin, albumin, triglyceride, glucose, serum bicarbonate