Infant, Premature, DiseasesNCT02372136
Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
A study testing Individualized Nutrition and Optimized nutrition in people with Infant, Premature, Diseases and Infant, Small for Gestational Age, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on growth rate and serum analyses). Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Infant, Premature, Diseases, Infant, Small for Gestational Age
- What is being tested?
- Individualized Nutrition and Optimized nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants <29 weeks GA and SGA infants <35 weeks GA born at Parkland Health and Hospital System
- Maternal plan to breastfeed or to use milk from the donor milk bank
- From birth to 1 week of life
Who cannot join
- Patients on comfort care only
- Patients with major congenital abnormalities
- Patients who are too unstable for the first 7 days to have an accurate length measurement
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75390-9063
About this study
Official title: Individualizing and Optimizing Nutrition to Prevent Metabolic Syndrome and To Improve Neurodevelopment in Preterm and Small for Gestational Age Infants
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on growth rate and serum analyses).
The first specific aim will determine whether individualized and optimized nutrition during hospitalization results in improved growth in the neonatal intensive care unit (NICU) in extremely low gestational age (GA) neonates (ELGANs, <29 weeks) and in small for GA (SGA, birth weight <10th percentile for GA) preterm infants compared with optimized nutrition.
The second specific aim will determine whether individualized and optimized nutrition in the NICU improves neurodevelopmental outcomes (acquisition of development milestones) and reduces the risk of disproportionate growth (i.e., excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.
Read the detailed description
Hypotheses:
- Primary hypothesis: In preterm infants (GA <29 weeks or GA <35 weeks and SGA) individualized and optimized nutrition will increase velocity of growth (weight gain velocity by 2 g x kg-1 x day-1 and length velocity by 0.2 cm per week) from birth to 36 weeks of postmenstrual age (GA plus postnatal age) or discharge (whichever comes first) in comparison with optimized nutrition.
- Secondary hypotheses: Individualized and optimized nutrition will improve neurodevelopmental outcome and reduce the risk of disproportionate growth (excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.
Study design:
Double-blinded randomized controlled trial (RCT): After consent, 150 neonates will be randomized to one of two groups.
Study intervention: Patients will be randomized to either:
- Control: optimized nutrition: Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen and albumin and velocity of growth (weight and length).
- Intervention: Individualized and optimized nutrition: Milk fortification will be optimized as in control neonates. In addition, nutrition will be individualized every day. Milk fortification will be adjusted based on daily measurements of macronutrients in human milk using near-infrared analysis.
Randomization will be done by computer provided by a statistician using random block allocation and stratification by GA and size for age (AGA [appropriate for GA] 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks). Twins and multiples will be randomized to the same arm of the study.
- Being tested
- Individualized Nutrition, Optimized nutrition
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized NutritionDietary supplement
Also called Targeted, customized
Intake of macronutrients (protein, fat, and carbohydrate) will be individualized every day by adding one or more macronutrients to human milk based on daily measurements using near-infrared analysis.
In patients receiving less milk than 140 ml x kg-1 x day-1 fortification of human milk will be adjusted to reach at least the average concentrations of protein, fat, and carbohydrate in donor's milk (Wojcik. J Am Diet Assoc. 2009 Jan;109:137-40) and 20 cal/oz as provided by the Mother's Milk Bank of North Texas.
In those receiving at least 140 ml x kg-1 x day-1 of milk at 24 cal/oz fortification will be adjusted to meet recent guidelines from the the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition (ESPGHAN) (Agostoni et al. J Pediatr Gastroenterol Nutr. 2010 Jan;50:85-91).
Optimized nutritionDietary supplement
Also called Adjustable
Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen (corrected for serum creatinine level) and albumin and velocity of growth (weight and length).
| Study group | Role | What they receive |
|---|---|---|
| Individualized and Optimized Nutrition | Experimental | Individualized nutrition Optimized nutrition Receives: Dietary Supplement: Individualized Nutrition; Dietary Supplement: Optimized nutrition |
| Optimized Nutrition | Other | Optimized nutrition Receives: Dietary Supplement: Optimized nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Velocity
Rate of weight gain [g x kg-1 x day-1] and length velocity [cm x week-1]
Measured: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Linear Growth Velocity
Increase in body length per week from birth to 36 weeks postmenstrual age or discharge
Measured: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Secondary outcomes (14)
Disproportionate Growth (Increased Fat Mass): BMI >90th Centile
Disproportionate growth (increased fat mass): BMI > 90th centile for sex and age
Measured: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Blood Pressure
Systolic blood pressure (calm or sleeping)
Measured: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Hypertension or High Systolic Blood Pressure
Systolic blood pressure >90th centile defined by the SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN
Measured: at 33-48 months adjusted age
Neurodevelopment
Bayley Scale of Infant and Toddler Development, Third Edition (BSID-III): cognitive composite score Higher scores mean a better outcome. The composite scaled score has a mean of 100 and a SD of 15, a floor of 55 and a ceiling of 145.
Bayley, N. (2006). Bayley Scales of Infant and Toddler Development- Third Edition. San Antonio, TX: Harcourt Assessment.
DOI: 10.1177/0734282906297199
Measured: 18-41 months adjusted age (postnatal age corrected for prematurity)
Neurodevelopment
Bayley Scale of Infant and Toddler Development, Third Edition (BSID-III): language composite score Higher scores mean a better outcome. The composite scaled score has a mean of 100 and a SD of 15, a floor of 47 and a ceiling of 153.
Bayley, N. (2006). Bayley Scales of Infant and Toddler Development- Third Edition. San Antonio, TX: Harcourt Assessment.
DOI: 10.1177/0734282906297199
Measured: 18-41 months adjusted age (postnatal age corrected for prematurity) 18-41 months adjusted age (postnatal age corrected for prematurity) 18-41 months corrected age 18-41 months
Leptin
Serum levels of leptin (measure of adiposity)
Measured: 33-48 months adjusted age
Renal Function
Serum level of cystatin C. This value increases if renal glomerular filtration decreases.
Measured: 33-48 months adjusted age
Comparison of Weight With Expected Value for Age and Gender
Comparison of weight with expected value for age and gender: Z score for weight Expected mean for age and gender is zero. Normal is -2 to +2. Best is zero with concomitant zero for length.
Measured: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Comparison of Length With Expected Value for Age and Gender
Comparison of length with expected value for age and gender: Z score for length Expected mean for age and gender is zero. Normal is -2 to +2. Best is zero with concomitant zero for weight.
Measured: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Comparison of Head Size With Expected Value for Age and Gender
Comparison of head size with expected value for age and gender: Z score for fronto-occipital circumference Expected mean for age and gender is zero. Normal is -2 to +2. Best is zero.
Measured: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Rate of Weight Gain
Rate of weight gain
Measured: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Rate of Linear Growth
Rate of linear growth
Measured: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Comparison of Rate of Head Growth With Expected Value for Age and Gender
Change in z score for fronto-occipital circumference from birth to endpoint Expected mean for age and gender is zero. Normal is -2 to +2.
Measured: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Body Composition
Percent fat mass measured by Dexascan
Measured: at 1 year of age and 3 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Medical Center Dallas, The Gerber Foundation
- Responsible party
- Principal investigator, Luc P. Brion, MD, University of Texas Southwestern Medical Center
- Investigators
- Luc P Brion, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372136
- Sponsor's protocol ID
- STU 102014-056
- Status last verified
- Jun 2024
- First submitted
- 12 Feb 2015
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The datasets generated and/or analyzed during the current study will be available from the corresponding author on reasonable request after completion and publication of all follow-up data.
Publications
Brion LP, Rosenfeld CR, Heyne R, Brown LS, Lair CS, Petrosyan E, Jacob T, Caraig M, Burchfield PJ. Optimizing individual nutrition in preterm very low birth weight infants: double-blinded randomized controlled trial. J Perinatol. 2020 Apr;40(4):655-665. doi: 10.1038/s41372-020-0609-1. Epub 2020 Feb 18.
PubMed 32071367Reis JD, Heyne R, Rosenfeld CR, Caraig M, Brown LS, Burchfield PJ, Lair CS, Petrosyan E, Jabob T, Nelson DB, Brion LP. Follow-up of a randomized trial optimizing neonatal nutrition in preterm very low birthweight infants: growth, serum adipokines, renal function and blood pressure. J Perinatol. 2024 Jan;44(1):78-86. doi: 10.1038/s41372-023-01821-2. Epub 2023 Nov 14.
PubMed 37964083Reis JD, Tolentino-Plata K, Caraig M, Heyne R, Rosenfeld CR, Brown LS, Brion LP. Double-blinded randomized controlled trial of optimizing nutrition in preterm very low birth weight infants: Bayley scores at 18-38 months of age. J Perinatol. 2023 Jan;43(1):81-85. doi: 10.1038/s41372-022-01572-6. Epub 2022 Dec 6.
PubMed 36473929
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualizing and Optimizing Nutrition to Prevent Metabolic Syndrome and To Improve Neurodevelopment in Preterm and Small for Gestational Age Infants
- ClinicalTrials.gov ID
- NCT02372136
- Acronym / sponsor ID
- STU 102014-056
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Children's Medical Center Dallas, The Gerber Foundation
- Study start
- Jan 2016
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Posted 20 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on growth rate and serum analyses).
The first specific aim will determine whether individualized and optimized nutrition during hospitalization results in improved growth in the neonatal intensive care unit (NICU) in extremely low gestational age (GA) neonates (ELGANs, <29 weeks) and in small for GA (SGA, birth weight <10th percentile for GA) preterm infants compared with optimized nutrition.
The second specific aim will determine whether individualized and optimized nutrition in the NICU improves neurodevelopmental outcomes (acquisition of development milestones) and reduces the risk of disproportionate growth (i.e., excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.
Detailed description
Hypotheses:
- Primary hypothesis: In preterm infants (GA <29 weeks or GA <35 weeks and SGA) individualized and optimized nutrition will increase velocity of growth (weight gain velocity by 2 g x kg-1 x day-1 and length velocity by 0.2 cm per week) from birth to 36 weeks of postmenstrual age (GA plus postnatal age) or discharge (whichever comes first) in comparison with optimized nutrition.
- Secondary hypotheses: Individualized and optimized nutrition will improve neurodevelopmental outcome and reduce the risk of disproportionate growth (excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.
Study design:
Double-blinded randomized controlled trial (RCT): After consent, 150 neonates will be randomized to one of two groups.
Study intervention: Patients will be randomized to either:
- Control: optimized nutrition: Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen and albumin and velocity of growth (weight and length).
- Intervention: Individualized and optimized nutrition: Milk fortification will be optimized as in control neonates. In addition, nutrition will be individualized every day. Milk fortification will be adjusted based on daily measurements of macronutrients in human milk using near-infrared analysis.
Randomization will be done by computer provided by a statistician using random block allocation and stratification by GA and size for age (AGA [appropriate for GA] 23-28 weeks, SGA 23-28 weeks and SGA 29-34 weeks). Twins and multiples will be randomized to the same arm of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized and Optimized Nutrition | Experimental | Dietary Supplement: Individualized Nutrition, Dietary Supplement: Optimized nutritionIndividualized nutrition Optimized nutrition |
| Optimized Nutrition | Other | Dietary Supplement: Optimized nutritionOptimized nutrition |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants <29 weeks GA and SGA infants <35 weeks GA born at Parkland Health and Hospital System
- Maternal plan to breastfeed or to use milk from the donor milk bank
- From birth to 1 week of life
Key exclusion criteria (3 listed)
- Patients on comfort care only
- Patients with major congenital abnormalities
- Patients who are too unstable for the first 7 days to have an accurate length measurement
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 |
|---|---|---|
| Individualized NutritionAlso: Targeted, customizedIntake of macronutrients (protein, fat, and carbohydrate) will be individualized every day by adding one or more macronutrients to human milk based on daily measurements using near-infrared analysis. In patients receiving less milk than 140 ml x kg-1 x day-1 fortification of human milk will be adjusted to reach at least the average concentrations of protein, fat, and carbohydrate in donor's milk (Wojcik. J Am Diet Assoc. 2009 Jan;109:137-40) and 20 cal/oz as provided by the Mother's Milk Bank of North Texas. In those receiving at least 140 ml x kg-1 x day-1 of milk at 24 cal/oz fortification will be adjusted to meet recent guidelines from the the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition (ESPGHAN) (Agostoni et al. J Pediatr Gastroenterol Nutr. 2010 Jan;50:85-91). | Dietary supplement | Individualized and Optimized Nutrition |
| Optimized nutritionAlso: AdjustableMilk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen (corrected for serum creatinine level) and albumin and velocity of growth (weight and length). | Dietary supplement | Individualized and Optimized Nutrition, Optimized Nutrition |
Primary outcome
Growth Velocity
Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Rate of weight gain [g x kg-1 x day-1] and length velocity [cm x week-1]
Linear Growth Velocity
Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Increase in body length per week from birth to 36 weeks postmenstrual age or discharge
14 secondary outcomes
Disproportionate Growth (Increased Fat Mass): BMI >90th Centile
Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Blood Pressure
Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Hypertension or High Systolic Blood Pressure
Time frame: at 33-48 months adjusted age
Neurodevelopment
Time frame: 18-41 months adjusted age (postnatal age corrected for prematurity)
Neurodevelopment
Time frame: 18-41 months adjusted age (postnatal age corrected for prematurity) 18-41 months adjusted age (postnatal age corrected for prematurity) 18-41 months corrected age 18-41 months
Leptin
Time frame: 33-48 months adjusted age
Renal Function
Time frame: 33-48 months adjusted age
Comparison of Weight With Expected Value for Age and Gender
Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Comparison of Length With Expected Value for Age and Gender
Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Comparison of Head Size With Expected Value for Age and Gender
Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Rate of Weight Gain
Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Rate of Linear Growth
Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Comparison of Rate of Head Growth With Expected Value for Age and Gender
Time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)
Body Composition
Time frame: at 1 year of age and 3 years of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32071367Brion LP, Rosenfeld CR, Heyne R, Brown LS, Lair CS, Petrosyan E, Jacob T, Caraig M, Burchfield PJ. Optimizing individual nutrition in preterm very low birth weight infants: double-blinded randomized controlled trial. J Perinatol. 2020 Apr;40(4):655-665. doi: 10.1038/s41372-020-0609-1. Epub 2020 Feb 18.
- Derived from this study: PubMed 37964083Reis JD, Heyne R, Rosenfeld CR, Caraig M, Brown LS, Burchfield PJ, Lair CS, Petrosyan E, Jabob T, Nelson DB, Brion LP. Follow-up of a randomized trial optimizing neonatal nutrition in preterm very low birthweight infants: growth, serum adipokines, renal function and blood pressure. J Perinatol. 2024 Jan;44(1):78-86. doi: 10.1038/s41372-023-01821-2. Epub 2023 Nov 14.
- Derived from this study: PubMed 36473929Reis JD, Tolentino-Plata K, Caraig M, Heyne R, Rosenfeld CR, Brown LS, Brion LP. Double-blinded randomized controlled trial of optimizing nutrition in preterm very low birth weight infants: Bayley scores at 18-38 months of age. J Perinatol. 2023 Jan;43(1):81-85. doi: 10.1038/s41372-022-01572-6. Epub 2022 Dec 6.
- DOILink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analyzed during the current study will be available from the corresponding author on reasonable request after completion and publication of all follow-up data.
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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.
Luc P Brion, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Nutrition and Optimized nutrition in people with Infant, Premature, Diseases and Infant, Small for Gestational Age, run by University of Texas Southwestern Medical Center 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 3 inclusion and 3 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 3 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 20 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Growth Velocity (time frame: 36 (range 35-37) weeks postmenstrual age or discharge (whichever comes first)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02372136, which also lists 3 linked publications.
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 3 Jul 2024.