Premature BirthNCT04525872
Parenteral Nutrition Light Protection and Premature Outcomes
A study testing Full parenteral nutrition light protection of the bag, tubing and lipids in people with Premature Birth, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Full parenteral nutrition light protection of the bag, tubing and lipids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2020to 26 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Premature Birth
- Being tested
- Full parenteral nutrition light protection of the bag, tubing and lipids
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full parenteral nutrition light protection of the bag, tubing and lipidsOther
Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.
| Study group | Role | What they receive |
|---|---|---|
| Premature infants | Experimental | 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 Receives: Other: Full parenteral nutrition light protection of the bag, tubing and lipids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of direct bilirubin
Change from baseline
Measured: Baseline, 2 weeks after the end of IV nutrition
Serum levels of liver enzymes
Change from baseline
Measured: Baseline, 2 weeks after the end of IV nutrition
Serum levels of triglycerides
Change from baseline
Measured: Baseline, 2 weeks after the end of IV nutrition
Serum levels of carnitine
Change from baseline
Measured: Baseline, 2 weeks after the end of IV nutrition
Serum levels of total bilirubin
Change from baseline
Measured: Baseline, 2 weeks after the end of IV nutrition
Secondary outcomes (5)
Oxidative stress
Change from baseline
Measured: Baseline, 2 weeks after the end of IV nutrition
Incidence of bronchopulmonary disease (BPD)
Measured: 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)
Measured: 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)
Measured: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Mortality
Measured: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start10 Jul 2020
- Primary completion15 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caterina Tiozza, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525872
- Sponsor's protocol ID
- 20-00378
- Status last verified
- Oct 2022
- First submitted
- 24 Jul 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: caterina.tiozzo@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Nutrition Light Protection and Premature Outcomes
- ClinicalTrials.gov ID
- NCT04525872
- Acronym / sponsor ID
- 20-00378
- Conditions
- Premature Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature infants | Experimental | Other: Full parenteral nutrition light protection of the bag, tubing and lipidsPremature 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 |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full parenteral nutrition light protection of the bag, tubing and lipidsEach infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing. | Other | Premature infants |
Primary outcome
Serum levels of direct bilirubin
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Serum levels of liver enzymes
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Serum levels of triglycerides
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Serum levels of carnitine
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Serum levels of total bilirubin
Time frame: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
5 secondary outcomes
Oxidative stress
Time frame: Baseline, 2 weeks after the end of IV nutrition
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
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
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
Mortality
Time frame: Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: caterina.tiozzo@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Premature Birth
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caterina Tiozza, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full parenteral nutrition light protection of the bag, tubing and lipids in people with Premature Birth, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of direct bilirubin (time frame: Baseline, 2 weeks after the end of IV nutrition). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.