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OpenTrials
Completed

NCT Number: NCT04525872

Parenteral Nutrition Light Protection and Premature Outcomes

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.

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Key information

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full parenteral nutrition light protection of the bag, tubing and lipids

Other

Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.

Primary outcomes

  1. Serum levels of direct bilirubin

    Time frame: Baseline, 2 weeks after the end of IV nutrition

    Change from baseline

  2. Serum levels of liver enzymes

    Time frame: Baseline, 2 weeks after the end of IV nutrition

    Change from baseline

  3. Serum levels of triglycerides

    Time frame: Baseline, 2 weeks after the end of IV nutrition

    Change from baseline

  4. Serum levels of carnitine

    Time frame: Baseline, 2 weeks after the end of IV nutrition

    Change from baseline

  5. Serum levels of total bilirubin

    Time frame: Baseline, 2 weeks after the end of IV nutrition

    Change from baseline

Secondary outcomes

  1. Oxidative stress

    Time frame: Baseline, 2 weeks after the end of IV nutrition

    Change from baseline

  2. Incidence of bronchopulmonary disease (BPD)

    Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition

  3. Incidence of retinopathy of prematurity (ROP)

    Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition

  4. Incidence of necrotizing enterocolitis (NEC)

    Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition

  5. Mortality

    Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2020
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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