Parenteral Nutrition Light Protection and Premature Outcomes

Premature Birth Clinical Trial

Official title:

Parenteral Nutrition Light Protection and Premature Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525872
• Other study ID #: 20-00378
• Status: Completed
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: July 26, 2022

Study information

• Verified date: October 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 26, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• Full 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of direct bilirubin	Change from baseline	Baseline, 2 weeks after the end of IV nutrition
Primary	Serum levels of liver enzymes	Change from baseline	Baseline, 2 weeks after the end of IV nutrition
Primary	Serum levels of triglycerides	Change from baseline	Baseline, 2 weeks after the end of IV nutrition
Primary	Serum levels of carnitine	Change from baseline	Baseline, 2 weeks after the end of IV nutrition
Primary	Serum levels of total bilirubin	Change from baseline	Baseline, 2 weeks after the end of IV nutrition
Secondary	Oxidative stress	Change from baseline	Baseline, 2 weeks after the end of IV nutrition
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality		Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition