Premature Birth
Conditions
Brief summary
Investigators propose a prospective study to investigate the effect of full light protection of the PN on cholestasis and other oxidative stress associated diseases in premature infants when they receive PN for more than one week. Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing. Demographic characteristics, clinical outcomes (incidence of cholestasis, feeding tolerance, BPD, ROP, NEC and mortality) and oxidative stress markers (e.g., carboxyhemeglobin) will be evaluated. Phase one of this study employed a retrospective chart review methodology to evaluate the effect of no PN light protection vs partial PN light protection (PN solution only while it's the tubing and lipids remained exposed to light). Infants from phase one of this study will serve as the controls in the evaluation the effect of full PN light protection on the cholestasis, clinical outcomes and oxidative stress. Investigators propose to collect urine and saliva samples in infants who we expect to receive PN for a minimum of 5 days, on days 0, 3, 5 and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition to evaluate oxidative stress.
Interventions
OTHERFull parenteral nutrition light protection of the bag, tubing and lipids
Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* Preterm infants \<32 weeks of gestation, who receive TPN for a minimum of 5 days * Infants with gastrointestinal surgical problems (e.g., ileal atresia, gastroschisis), expected to receive TPN for a minimum of 5 days
Exclusion criteria
* Infants who receive TPN for \<5 days * Infants who developed cholestasis due to non-TPN-related causes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of total bilirubin | Baseline, 2 weeks after the end of IV nutrition | Change from baseline |
| Serum levels of direct bilirubin | Baseline, 2 weeks after the end of IV nutrition | Change from baseline |
| Serum levels of liver enzymes | Baseline, 2 weeks after the end of IV nutrition | Change from baseline |
| Serum levels of triglycerides | Baseline, 2 weeks after the end of IV nutrition | Change from baseline |
| Serum levels of carnitine | Baseline, 2 weeks after the end of IV nutrition | Change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative stress | Baseline, 2 weeks after the end of IV nutrition | Change from baseline |
| Incidence of bronchopulmonary disease (BPD) | Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition | — |
| Incidence of retinopathy of prematurity (ROP) | Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition | — |
| Incidence of necrotizing enterocolitis (NEC) | Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition | — |
| Mortality | Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition | — |
Countries
United States
Outcome results
None listed