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OpenTrials
Completed

NCT Number: NCT04860583

Nephrocalcinosis in Very Low Birth Weight Infants

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Newborns with kidney malformation

Treatment and study plan

Renal ultrasound

Other

Primary outcomes

  1. Prevalence of nephrocalcinosis

    Time frame: At week 35 of corrected gestational age

    Presence/absence of nephrocalcinosis will be checked by ultrasound

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Nephrocalcinosis in Very Low Birth Weight Infants: an Observational Study

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2021
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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