NCT02813109

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

June 20, 2016

Last Update Submit

April 27, 2017

Conditions

Premature Infant

Outcome Measures

Primary Outcomes (4)

  • correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine

    postnatal 1day

  • correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine

    postnatal 3day

  • correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine

    postnatal 5day

  • correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine

    postnatal 7day

Eligibility Criteria

Age1 Day - 2 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

below gestational age 37 weeks

You may qualify if:

  • premature infants born before 37 weeks of gestational age

You may not qualify if:

  • cardiac or renal anomalies
  • transferred in 2 days after birth from other hospitals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Inha University Hospital

Incheon, 22332, South Korea

Location

Hallym University Medical Center - Kangnam

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 24, 2016

Study Start

June 1, 2016

Primary Completion

February 15, 2017

Study Completion

March 2, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

KR(2)