NCT02837276

Brief Summary

This pilot study aims at investigating the relationship between intermittent hypoxemia (IH) and acute kidney injury (AKI) in preterm infants. AIM 1: Test the hypothesis that intermittent hypoxemia is associated kidney injury in preterm infants, as reflected by a rise in serum creatinine. AIM 2: Test the hypothesis that there is rise in acute kidney injury urinary biomarkers with increased intermittent hypoxemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

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

July 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

July 14, 2016

Last Update Submit

August 29, 2019

Conditions

Intermittent HypoxemiaAcute Kidney InjuryPreterm Infant

Keywords

Intermittent HypoxemiaAcute Kidney InjuryPreterm infant

Outcome Measures

Primary Outcomes (1)

  • Test the hypothesis that intermittent hypoxemia is associated with acute kidney injury, as reflected by a rise in creatinine or urinary biomarkers

    1 year

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm infants less than 32 weeks gestational age.

You may qualify if:

  • Preterm infants less than 32 weeks gestational age admitted to University of Kentucky neonatal intensive care unit

You may not qualify if:

  • Major congenital malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky - Kentucky Children's Hospital

Lexington, Kentucky, 40536, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Acute Kidney InjuryPremature Birth

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy Complications

Study Officials

  • Elie G Abu Jawdeh, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

  • Mina H Hanna, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 19, 2016

Study Start

July 1, 2016

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

September 4, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)