NephrocalcinosisNCT04382976
The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants
An observational study of Nephrocalcinosis and Preterm Infant, run by Vilnius University at 1 site in Lithuania.
Trial summary
The study aims to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants using patient data collected during hospitalisation at the Neonatology Centre. Read more about this study
- Who is it for?
- Ages 23 to 31 weeks
- Conditions the study is for
- Nephrocalcinosis, Preterm Infant
- How many people
- 171 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Oct 2018to 1 Oct 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 23 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Study population: The study population is a group of very preterm infants less than 32 weeks of gestation during hospitalisation at the Neonatology Centre.
Who may be able to join
- preterm infants of the gestational age of <32 weeks;
- parental consent acquired.
Who cannot join
- death before 28 days of age;
- congenital defects;
- no kidney ultrasound results;
- no parental consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants at the Neonatology Centre of Vilnius University Hospital Santaros Klinikos
The study aims to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants using patient data collected during hospitalisation at the Neonatology Centre.
Read the detailed description
Nephrocalcinosis in preterm infants develops as a result of imbalance between the factors promoting or inhibiting formation of kidney stones. It is caused by intensive treatment as well as functional and morphological kidney immaturity. There is a correlation between the prevalence of nephrocalcinosis and low gestational age.
The study aims prospectively to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants less than 32 weeks of gestation.
- Conditions
- Nephrocalcinosis, Preterm Infant
- Medical subject headings
- Nephrocalcinosis, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of nephrocalcinosis in very preterm infants less than 32 weeks of gestation
Kidney ultrasound results will divide preterm infants in the group with and without nephrocalcinosis (control).
Measured: 3 years
Secondary outcomes (2)
Compare demographic, clinical, biochemical and treatment results between nephrocalcinosis and the control (without nephrocalcinosis) groups.
Patients data (demographic, clinical, biochemical and treatment results) collected during hospitalisation at the Neonatology Centre will be compared between nephrocalcinosis and control group.
Measured: 3 years
To evaluate the dynamics of nephrocalcinosis at 6 and 12 months of corrected age.
Nephrologist consultation of the infants with nephrocalcinosis at 6 and 12 months of corrected age
Measured: 6 and 12 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Oct 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrocalcinosisStudies 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
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rasa Garunkstiene, PhD, Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382976
- Sponsor's protocol ID
- 158200-R-100
- Status last verified
- Dec 2021
- First submitted
- 6 May 2020
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants at the Neonatology Centre of Vilnius University Hospital Santaros Klinikos
- ClinicalTrials.gov ID
- NCT04382976
- Acronym / sponsor ID
- 158200-R-100
- Conditions
- Nephrocalcinosis, Preterm Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 11 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.
The study aims to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants using patient data collected during hospitalisation at the Neonatology Centre.
Detailed description
Nephrocalcinosis in preterm infants develops as a result of imbalance between the factors promoting or inhibiting formation of kidney stones. It is caused by intensive treatment as well as functional and morphological kidney immaturity. There is a correlation between the prevalence of nephrocalcinosis and low gestational age.
The study aims prospectively to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants less than 32 weeks of gestation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population is a group of very preterm infants less than 32 weeks of gestation during hospitalisation at the Neonatology Centre.
Key inclusion criteria (2 listed)
- preterm infants of the gestational age of <32 weeks;
- parental consent acquired.
Key exclusion criteria (4 listed)
- death before 28 days of age;
- congenital defects;
- no kidney ultrasound results;
- no parental consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of nephrocalcinosis in very preterm infants less than 32 weeks of gestation
Time frame: 3 years
Kidney ultrasound results will divide preterm infants in the group with and without nephrocalcinosis (control).
2 secondary outcomes
Compare demographic, clinical, biochemical and treatment results between nephrocalcinosis and the control (without nephrocalcinosis) groups.
Time frame: 3 years
To evaluate the dynamics of nephrocalcinosis at 6 and 12 months of corrected age.
Time frame: 6 and 12 months of corrected age
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 23 Dec 2021.
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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.
Rasa Garunkstiene, PhD principal investigator
Vilnius University
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 Nephrocalcinosis and Preterm Infant, run by Vilnius University at 1 site in Lithuania.
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 2 inclusion and 4 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 23 Dec 2021. 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 Lithuania. 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?
The incidence of nephrocalcinosis in very preterm infants less than 32 weeks of gestation (time frame: 3 years). 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 23 Dec 2021.