GrowthTargetFortNCT04400396
Effect of Target Fortified Human Milk on the Growth Quality of Very Preterm Infants (TargetFort)
An observational study of Growth and Body Composition, run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
Trial summary
It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018). Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Growth, Body Composition, Prematurity
- What is being tested?
- standard HM fortification and target HM fortification
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2020to 16 Dec 2021
- Phase
- Observational
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Very preterm newborn infants (born at <33 weeks) that achieve full enteral feeding exclusively or predominantly with human milk
Who may be able to join
- newborn infants born at <33 weeks of gestation,
- admitted to the NICU of Maternidade Dr. Alfredo da Costa (inborns and outborns),
- exclusively or predominantly HM fed (>87.5% volume per day)
- discharged alive.
Who cannot join
- multiples of grade >2
- diagnosis of innate metabolism disorder,
- fed with formula for >12.5% of the daily volume intake for two or more consecutive full days ,
- discharge with transference to other hospital,
- unavailable for body composition analysis after discharge.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar Universitário de Lisboa Central
Lisbon, 1150-199
About this study
Official title: Effect of Target vs. Standard Human Milk Fortification on the Growth and Body Composition of Predominantly Human Milk Fed Very Preterm Infants
It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018). The target fortification, based on analysis of HM composition, is considered the gold-standard method (Rochow 2015, McLeod 2016). This observational mixed cohort study aims to assess if very preterm infants fed HM with target fortification have greater growth during hospital stay and better body composition at term post-menstrual age (PMA), than those fed HM with standard fortification.
Read the detailed description
Study design: observational mixed cohort study, comparing growth and body composition in a contemporary cohort of very preterm infants fed HM with target fortification, the currently adopted clinical practice, with a historical cohort of very preterm infants fed HM with standard fortification (Macedo AJP 2018).
Study periods: historical cohort from 1 February 2014 to 28 February 2015; contemporary cohort: start February 2020, estimated recruitment period of 16 months; Settings: Neonatal Care Unit (NICU) and Human Milk Bank at Maternidade Dr. Alfredo da Costa and Nutrition Laboratory at Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central.
Product to be analyzed: HM, including mother's own milk (MOM) and donor's milk (DHM). Donor HM is pasteurized using the Holder method (Peila 2016) which is adopted by the Human Milk Bank of Maternidade Dr. Alfredo da Costa (Macedo MHNP 2018).
Demographic variables: Gestational age, sex, singleton or twin, birth weight, small-, appropriate- or large-for-gestational age (<3rd percentile, ≥3rd percentile and ≤97th percentile, >97th percentile, respectively) (Fenton 2013), severity index (SNAPPE II) (Richardson 2001), use of prenatal corticosteroids, diagnosis of late sepsis (Modi 2009), necrotizing enterocolitis (grade ≥ 3) (Bell 1971), intraperiventricular hemorrhage (grade ≥ 3) (Papile 1978), multicystic periventricular leukomalacia (de Vries 1992), and chronic lung disease (Becker 1984).
Method of collection and analysis of HM: as described in a previous study (Macedo MHNP 2018), in order to minimize daily variability of breast milk composition, mothers are asked to save milk collected through 24 hours in the same container. The HM composition (MOM and DHM) are analyzed using the Miris human milk analyzer (Miris AB, Uppsala, Sweden), following the method described in a previous study (Macedo MHNP 2018). The composition is expressed in densities: Kcal/dL of energy and g/dl of fat, raw and true protein, carbohydrates and ashes.
Energy and macronutrient composition of the multi-component HM fortifier and modular protein and fat supplements. For this purpose, an Excel program to calculate modular protein and fat supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M, Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February 2020).
Daily intakes of energy (Kcal/kg), protein (g/kg) and protein:energy ratio (P:E), based on administered volume of milk (ml/kg).
Anthropometric and body composition measurements in infants: According to the previously described method (Macedo AJP 2018), during the hospital stay, the same observer (MMC) measures daily the body weight (allowing the calculation of weight gain velocity), and weekly the length and the head circumference. Within the first week after discharge, body composition will be assessed using displacement plethysmography, to evaluate fat mass (FM), fat free mass (FFM), percentage of FM (%FM), percentage of FFM (%FFM) and FM index (FMI), as described in a previous study (Macedo AJP 2018). Both FMI and %FM are used as indicators of adiposity.
Estimate of sample size: The study sample size was calculated to detect a difference of 2 g/kg/day in growth velocity with a standard deviation 2.6 (Macedo, 2018; Tremblay, 2017) for normally distributed variables, a significance level of 0.05, and an 80% power; thus, a required sample of 67 infants (n1=33; n2+20%=34) was estimated.
- Conditions
- Growth, Body Composition, Prematurity, Breast Milk Collection, Nutrient Deficiency, Feeding Patterns
- Being tested
- standard HM fortification, target HM fortification
- Medical subject headings
- Premature Birth, Breast Milk Expression, Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard HM fortificationDietary supplement
Based on the assumed energy and macronutrient composition of HM, the commercial multi-component HM fortifier was added, in order to compensate identified nutritional deficits.
target HM fortificationDietary supplement
Based on the measured energy and macronutrient composition of HM, modular protein and fat supplements are added, in addition to the commercial multi-component HM fortifier, in order to correct identified specific nutritional deficits. For this purpose, an Excel program to calculate modular protein and fat supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M, Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February 2020)
| Study group | Role | What they receive |
|---|---|---|
| target HM fortification | Contemporary cohort fed HM with target fortification Receives: Dietary Supplement: target HM fortification | |
| standard HM fortification | Historical cohort fed HM with standard fortification Receives: Dietary Supplement: standard HM fortification |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain velocity rate
average relative daily variation of body weight
Measured: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
length velocity rate
average relative weekly variation of body length
Measured: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
head circumference velocity rate
average relative weekly variation of head circumference
Measured: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
adiposity (fat mass index)
ratio of fat mass over squared body length
Measured: A single measurement performed up to 10 days after home discharge
Secondary outcomes (1)
adiposity (fat mass percentage)
proportion of fat mass on total body mass
Measured: A single measurement performed up to 10 days after home discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Feb 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion16 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for GrowthStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Lisboa Central
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedade Portuguesa de Neonatologia
- Responsible party
- Sponsor
- Investigators
- Luis Pereira-da-Silva, MD, PhD, Study director, Universidade Nova de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400396
- Sponsor's protocol ID
- CHULC.CI512.2020
- Acronym
- TargetFort
- Status last verified
- Jun 2020
- First submitted
- 18 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Macedo I, Pereira-da-Silva L, Cardoso M. The fortification method relying on assumed human milk composition overestimates the actual energy and macronutrient intakes in very preterm infants. Matern Health Neonatol Perinatol. 2018 Sep 17;4:22. doi: 10.1186/s40748-018-0090-4. eCollection 2018.
PubMed 30237896McLeod G, Sherriff J, Hartmann PE, Nathan E, Geddes D, Simmer K. Comparing different methods of human breast milk fortification using measured v. assumed macronutrient composition to target reference growth: a randomised controlled trial. Br J Nutr. 2016 Feb 14;115(3):431-9. doi: 10.1017/S0007114515004614. Epub 2015 Dec 2.
PubMed 26627899Rochow N, Landau-Crangle E, Fusch C. Challenges in breast milk fortification for preterm infants. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):276-84. doi: 10.1097/MCO.0000000000000167.
PubMed 25807355Macedo I, Pereira-da-Silva L, Cardoso M. Associations of Measured Protein and Energy Intakes with Growth and Adiposity in Human Milk-Fed Preterm Infants at Term Postmenstrual Age: A Cohort Study. Am J Perinatol. 2018 Jul;35(9):882-891. doi: 10.1055/s-0038-1626717. Epub 2018 Feb 2.
PubMed 29532450Henriksen C, Westerberg AC, Ronnestad A, Nakstad B, Veierod MB, Drevon CA, Iversen PO. Growth and nutrient intake among very-low-birth-weight infants fed fortified human milk during hospitalisation. Br J Nutr. 2009 Oct;102(8):1179-86. doi: 10.1017/S0007114509371755. Epub 2009 May 18.
PubMed 19445820Maas C, Wiechers C, Bernhard W, Poets CF, Franz AR. Early feeding of fortified breast milk and in-hospital-growth in very premature infants: a retrospective cohort analysis. BMC Pediatr. 2013 Nov 4;13:178. doi: 10.1186/1471-2431-13-178.
PubMed 24180239Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y.
PubMed 27370649Polberger S. New approaches to optimizing early diets. Nestle Nutr Workshop Ser Pediatr Program. 2009;63:195-204; discussion 204-8, 259-68. doi: 10.1159/000209982.
PubMed 19346777Cardoso M, Virella D, Macedo I, Silva D, Pereira-da-Silva L. Customized Human Milk Fortification Based on Measured Human Milk Composition to Improve the Quality of Growth in Very Preterm Infants: A Mixed-Cohort Study Protocol. Int J Environ Res Public Health. 2021 Jan 19;18(2):823. doi: 10.3390/ijerph18020823.
PubMed 33477964
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Target vs. Standard Human Milk Fortification on the Growth and Body Composition of Predominantly Human Milk Fed Very Preterm Infants
- ClinicalTrials.gov ID
- NCT04400396
- Acronym / sponsor ID
- TargetFort / CHULC.CI512.2020
- Conditions
- Growth, Body Composition, Prematurity, Breast Milk Collection, Nutrient Deficiency, Feeding Patterns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centro Hospitalar de Lisboa CentralUniversity, hospital or other
- Collaborators
- Sociedade Portuguesa de Neonatologia
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 16 Dec 2021 (estimated)
- First posted
- 22 May 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.
It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018). The target fortification, based on analysis of HM composition, is considered the gold-standard method (Rochow 2015, McLeod 2016). This observational mixed cohort study aims to assess if very preterm infants fed HM with target fortification have greater growth during hospital stay and better body composition at term post-menstrual age (PMA), than those fed HM with standard fortification.
Detailed description
Study design: observational mixed cohort study, comparing growth and body composition in a contemporary cohort of very preterm infants fed HM with target fortification, the currently adopted clinical practice, with a historical cohort of very preterm infants fed HM with standard fortification (Macedo AJP 2018).
Study periods: historical cohort from 1 February 2014 to 28 February 2015; contemporary cohort: start February 2020, estimated recruitment period of 16 months; Settings: Neonatal Care Unit (NICU) and Human Milk Bank at Maternidade Dr. Alfredo da Costa and Nutrition Laboratory at Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central.
Product to be analyzed: HM, including mother's own milk (MOM) and donor's milk (DHM). Donor HM is pasteurized using the Holder method (Peila 2016) which is adopted by the Human Milk Bank of Maternidade Dr. Alfredo da Costa (Macedo MHNP 2018).
Demographic variables: Gestational age, sex, singleton or twin, birth weight, small-, appropriate- or large-for-gestational age (<3rd percentile, ≥3rd percentile and ≤97th percentile, >97th percentile, respectively) (Fenton 2013), severity index (SNAPPE II) (Richardson 2001), use of prenatal corticosteroids, diagnosis of late sepsis (Modi 2009), necrotizing enterocolitis (grade ≥ 3) (Bell 1971), intraperiventricular hemorrhage (grade ≥ 3) (Papile 1978), multicystic periventricular leukomalacia (de Vries 1992), and chronic lung disease (Becker 1984).
Method of collection and analysis of HM: as described in a previous study (Macedo MHNP 2018), in order to minimize daily variability of breast milk composition, mothers are asked to save milk collected through 24 hours in the same container. The HM composition (MOM and DHM) are analyzed using the Miris human milk analyzer (Miris AB, Uppsala, Sweden), following the method described in a previous study (Macedo MHNP 2018). The composition is expressed in densities: Kcal/dL of energy and g/dl of fat, raw and true protein, carbohydrates and ashes.
Energy and macronutrient composition of the multi-component HM fortifier and modular protein and fat supplements. For this purpose, an Excel program to calculate modular protein and fat supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M, Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February 2020).
Daily intakes of energy (Kcal/kg), protein (g/kg) and protein:energy ratio (P:E), based on administered volume of milk (ml/kg).
Anthropometric and body composition measurements in infants: According to the previously described method (Macedo AJP 2018), during the hospital stay, the same observer (MMC) measures daily the body weight (allowing the calculation of weight gain velocity), and weekly the length and the head circumference. Within the first week after discharge, body composition will be assessed using displacement plethysmography, to evaluate fat mass (FM), fat free mass (FFM), percentage of FM (%FM), percentage of FFM (%FFM) and FM index (FMI), as described in a previous study (Macedo AJP 2018). Both FMI and %FM are used as indicators of adiposity.
Estimate of sample size: The study sample size was calculated to detect a difference of 2 g/kg/day in growth velocity with a standard deviation 2.6 (Macedo, 2018; Tremblay, 2017) for normally distributed variables, a significance level of 0.05, and an 80% power; thus, a required sample of 67 infants (n1=33; n2+20%=34) was estimated.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| target HM fortification | – | Dietary Supplement: target HM fortificationContemporary cohort fed HM with target fortification |
| standard HM fortification | – | Dietary Supplement: standard HM fortificationHistorical cohort fed HM with standard fortification |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Very preterm newborn infants (born at <33 weeks) that achieve full enteral feeding exclusively or predominantly with human milk
Key inclusion criteria (4 listed)
- newborn infants born at <33 weeks of gestation,
- admitted to the NICU of Maternidade Dr. Alfredo da Costa (inborns and outborns),
- exclusively or predominantly HM fed (>87.5% volume per day)
- discharged alive.
Key exclusion criteria (5 listed)
- multiples of grade >2
- diagnosis of innate metabolism disorder,
- fed with formula for >12.5% of the daily volume intake for two or more consecutive full days ,
- discharge with transference to other hospital,
- unavailable for body composition analysis after discharge.
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 |
|---|---|---|
| standard HM fortificationBased on the assumed energy and macronutrient composition of HM, the commercial multi-component HM fortifier was added, in order to compensate identified nutritional deficits. | Dietary supplement | standard HM fortification |
| target HM fortificationBased on the measured energy and macronutrient composition of HM, modular protein and fat supplements are added, in addition to the commercial multi-component HM fortifier, in order to correct identified specific nutritional deficits. For this purpose, an Excel program to calculate modular protein and fat supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M, Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February 2020) | Dietary supplement | target HM fortification |
Primary outcome
weight gain velocity rate
Time frame: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
average relative daily variation of body weight
length velocity rate
Time frame: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
average relative weekly variation of body length
head circumference velocity rate
Time frame: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
average relative weekly variation of head circumference
adiposity (fat mass index)
Time frame: A single measurement performed up to 10 days after home discharge
ratio of fat mass over squared body length
1 secondary outcome
adiposity (fat mass percentage)
Time frame: A single measurement performed up to 10 days after home discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 30237896Macedo I, Pereira-da-Silva L, Cardoso M. The fortification method relying on assumed human milk composition overestimates the actual energy and macronutrient intakes in very preterm infants. Matern Health Neonatol Perinatol. 2018 Sep 17;4:22. doi: 10.1186/s40748-018-0090-4. eCollection 2018.
- Background: PubMed 26627899McLeod G, Sherriff J, Hartmann PE, Nathan E, Geddes D, Simmer K. Comparing different methods of human breast milk fortification using measured v. assumed macronutrient composition to target reference growth: a randomised controlled trial. Br J Nutr. 2016 Feb 14;115(3):431-9. doi: 10.1017/S0007114515004614. Epub 2015 Dec 2.
- Background: PubMed 25807355Rochow N, Landau-Crangle E, Fusch C. Challenges in breast milk fortification for preterm infants. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):276-84. doi: 10.1097/MCO.0000000000000167.
- Results publication: PubMed 29532450Macedo I, Pereira-da-Silva L, Cardoso M. Associations of Measured Protein and Energy Intakes with Growth and Adiposity in Human Milk-Fed Preterm Infants at Term Postmenstrual Age: A Cohort Study. Am J Perinatol. 2018 Jul;35(9):882-891. doi: 10.1055/s-0038-1626717. Epub 2018 Feb 2.
- Results publication: PubMed 19445820Henriksen C, Westerberg AC, Ronnestad A, Nakstad B, Veierod MB, Drevon CA, Iversen PO. Growth and nutrient intake among very-low-birth-weight infants fed fortified human milk during hospitalisation. Br J Nutr. 2009 Oct;102(8):1179-86. doi: 10.1017/S0007114509371755. Epub 2009 May 18.
- Results publication: PubMed 24180239Maas C, Wiechers C, Bernhard W, Poets CF, Franz AR. Early feeding of fortified breast milk and in-hospital-growth in very premature infants: a retrospective cohort analysis. BMC Pediatr. 2013 Nov 4;13:178. doi: 10.1186/1471-2431-13-178.
- Results publication: PubMed 27370649Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y.
- Results publication: PubMed 19346777Polberger S. New approaches to optimizing early diets. Nestle Nutr Workshop Ser Pediatr Program. 2009;63:195-204; discussion 204-8, 259-68. doi: 10.1159/000209982.
- Derived from this study: PubMed 33477964Cardoso M, Virella D, Macedo I, Silva D, Pereira-da-Silva L. Customized Human Milk Fortification Based on Measured Human Milk Composition to Improve the Quality of Growth in Very Preterm Infants: A Mixed-Cohort Study Protocol. Int J Environ Res Public Health. 2021 Jan 19;18(2):823. doi: 10.3390/ijerph18020823.
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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.
Luis Pereira-da-Silva, MD, PhD study director
Universidade Nova de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth and Body Composition, run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. 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 Portugal. 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?
Results are not available in the source record.
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?
weight gain velocity rate (time frame: from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first). The study lists 4 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 NCT04400396, which also lists 9 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 9 Jun 2020.