Nephrocalcinosis in Very Low Birth Weight Infants

NCT04860583 | Completed

• 1 other identifier: CRC_GHN_2021_001
• Study Type: observational
• Target: 265
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infant; Premature, Light-For-Dates

Outcome Measures

Primary Outcomes (1)

• Prevalence of nephrocalcinosis

  Presence/absence of nephrocalcinosis will be checked by ultrasound

  At week 35 of corrected gestational age

Interventions

Renal ultrasound OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Newborns with kidney malformation

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: January 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04