NCT04382976

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

December 23, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

May 6, 2020

Last Update Submit

December 22, 2021

Conditions

NephrocalcinosisPreterm Infant

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 years

Secondary Outcomes (2)

  • Compare demographic, clinical, biochemical and treatment results between nephrocalcinosis and the control (without nephrocalcinosis) groups.

    3 years

  • To evaluate the dynamics of nephrocalcinosis at 6 and 12 months of corrected age.

    6 and 12 months of corrected age

Eligibility Criteria

Age23 Weeks - 31 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population is a group of very preterm infants less than 32 weeks of gestation during hospitalisation at the Neonatology Centre.

You may qualify if:

  • preterm infants of the gestational age of \<32 weeks;
  • parental consent acquired.

You may not qualify if:

  • death before 28 days of age;
  • congenital defects;
  • no kidney ultrasound results;
  • no parental consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University, Neonatology Centre

Vilnius, 08464, Lithuania

Location

MeSH Terms

Conditions

NephrocalcinosisPremature Birth

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy Complications

Study Officials

  • Rasa Garunkstiene, PhD

    Vilnius University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

October 1, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

December 23, 2021

Record last verified: 2021-12

Locations

LI(1)