Parenteral Nutrition Light Protection and Premature Outcomes

NCT ID: NCT04525872

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2022-07-26

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Birth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Premature infants

Premature infants who are expected to receive TPN for a minimum of 5 days and infants with gastrointestinal surgical problems (e.g., ileal atresia, gastroschisis), expected to receive TPN for a minimum of 5 days

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Preterm infants \<32 weeks of gestation, who 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
Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caterina Tiozza, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20-00378

Identifier Type: -

Identifier Source: org_study_id

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