Nephrocalcinosis in Very Low Birth Weight Infants

Nephrocalcinosis in Very Low Birth Weight Infants: an Observational Study

Extremely premature children benefit from specific follow-up that requires high nutritional intake and the use of specific therapies that expose them to the risk of nephrocalcinosis. Other identified risk factors are extreme prematurity and intrauterine growth restriction.

The incidence of nephrocalcinosis in very premature infants is unclear, ranging from 7 to 64%. Most studies are observational and only few case-control studies can properly analyse the risk factors for nephrocalcinosis in significant populations that include only preterm infants.

This nephrocalcinosis of prematurity regresses spontaneously in more than half of the cases, but has been associated with a risk of long-term complications: impaired renal function, high blood pressure, etc. This is an aggravating factor in the context of prematurity, which has been associated with an increased risk of renal impairment and hypertension in childhood and adulthood.

For all these reasons, nutritional intakes and therapeutics are monitored very closely and a renal ultrasound is routinely performed at discharge at 35 weeks of corrected gestational age in all children who are born at a gestational age ≤ 32 weeks and/or birth weight ≤ 1500 g.

Study Overview

• Status: Completed
• Conditions: Infant; Premature, Light-For-Dates
• Intervention / Treatment: Other: Renal ultrasound

• Study Type: Observational
• Enrollment (Actual): 265

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants born at the Croix-Rousse Hospital, Lyon, France between 01/01/2012 and 31/12/2017 with a gestational age <= 32 weeks and/or a birthweight <=1500g. Infants with a diagnosed kidney malformation are excluded.

Description

Inclusion Criteria:

• Newborns with a gestational age <= 32 weeks and/or birthweight <=1500g

Exclusion Criteria:

• Newborns with kidney malformation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of nephrocalcinosis	Presence/absence of nephrocalcinosis will be checked by ultrasound	At week 35 of corrected gestational age

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Body Weight; Calcium Metabolism Disorders; Calcinosis; Birth Weight; Nephrocalcinosis
• Other Study ID Numbers: CRC_GHN_2021_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No