Premature InfantNCT02813109
Urine Biomarkers for Renal Function Monitoring in Preterm Infants
An observational study of Premature Infant, run by Inha University Hospital at 2 sites in South Korea.
Trial summary
The true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr) levels in infants are unreliable as a detector of renal function in the first few days of life because they may continue to reflect maternal levels. Read more about this study
- Who is it for?
- Ages 1 day to 2 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Infant
- How many people
- 83 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jun 2016to 2 Mar 2017
- 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 to 2 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: below gestational age 37 weeks
Who may be able to join
- premature infants born before 37 weeks of gestational age
Who cannot join
- cardiac or renal anomalies
- transferred in 2 days after birth from other hospitals
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Inha University Hospital
Incheon, 22332
Hallym University Medical Center - Kangnam
Seoul
About this study
The true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr) levels in infants are unreliable as a detector of renal function in the first few days of life because they may continue to reflect maternal levels. Although few candidates appear to be a useful biomarker for kidney injury, scant reference data on these biomarker in preterm infants exist, and studies have yielded conflicting results. Therefore, we aimed to determine the reliable urinary biomarkers to detect kidney injuries in preterm infants.
- Conditions
- Premature Infant
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Measured: postnatal 1day
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Measured: postnatal 3day
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Measured: postnatal 5day
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Measured: postnatal 7day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion15 Feb 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University Medical Center
- Responsible party
- Principal investigator, Juyoung Lee, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813109
- Sponsor's protocol ID
- U-BIO-16
- Status last verified
- Apr 2017
- First submitted
- 20 Jun 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Biomarkers for Renal Function Monitoring in Preterm Infants
- ClinicalTrials.gov ID
- NCT02813109
- Acronym / sponsor ID
- U-BIO-16
- Conditions
- Premature Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Collaborators
- Hallym University Medical Center
- Study start
- Jun 2016
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 24 Jun 2016 (estimated)
- 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 true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr) levels in infants are unreliable as a detector of renal function in the first few days of life because they may continue to reflect maternal levels. Although few candidates appear to be a useful biomarker for kidney injury, scant reference data on these biomarker in preterm infants exist, and studies have yielded conflicting results. Therefore, we aimed to determine the reliable urinary biomarkers to detect kidney injuries in preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 2 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- below gestational age 37 weeks
Key inclusion criteria (1 listed)
- premature infants born before 37 weeks of gestational age
Key exclusion criteria (2 listed)
- cardiac or renal anomalies
- transferred in 2 days after birth from other hospitals
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
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Time frame: postnatal 1day
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Time frame: postnatal 3day
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Time frame: postnatal 5day
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Time frame: postnatal 7day
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 28 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infant, run by Inha University Hospital at 2 sites in South Korea.
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 1 inclusion and 2 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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine (time frame: postnatal 1day). 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?
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 28 Apr 2017.