Clinical trial NCT04525872: Parenteral Nutrition Light Protection and Premature Outcomes
Official title: Parenteral Nutrition Light Protection and Premature Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 36
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum levels of direct bilirubin
timeFrame: Baseline, 2 weeks after the end of IV nutrition
measure: Serum levels of liver enzymes
timeFrame: Baseline, 2 weeks after the end of IV nutrition
measure: Serum levels of triglycerides
timeFrame: Baseline, 2 weeks after the end of IV nutrition
measure: Serum levels of carnitine
timeFrame: Baseline, 2 weeks after the end of IV nutrition
measure: Serum levels of total bilirubin
timeFrame: Baseline, 2 weeks after the end of IV nutrition
Secondary outcomes:
measure: Oxidative stress
timeFrame: Baseline, 2 weeks after the end of IV nutrition
measure: Incidence of bronchopulmonary disease (BPD)
timeFrame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
measure: Incidence of retinopathy of prematurity (ROP)
timeFrame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
measure: Incidence of necrotizing enterocolitis (NEC)
timeFrame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
measure: Mortality
timeFrame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Caterina Tiozza, MD
role: PRINCIPAL_INVESTIGATOR
References: