FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g (PremaVitaD)

March 11, 2024 updated by: Fondation Hôpital Saint-Joseph

Vitamin D plays an important role in phosphocalcic metabolism and bone homeostasis in newborns. Premature newborns are at risk of vitamin D deficiency and may require supplementation. In this context, the French Society of Pediatrics (Société Française de Pédiatrie) recommends systematic vitamin D testing at 1 month.

The aim of this study was to determine the frequency of vitamin D deficiency in premature newborns.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hopital Saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g

Description

Inclusion Criteria:

  • Premature newborns born at a gestational age less than 32 weeks and/or birth weight less than 1500g
  • Having received at least one dosage of 25 OH vitamin D.-

Exclusion Criteria:

  • - Newborn whose parents or legal guardian refuse the use of their data for this research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamine D deficiency frequency
Time Frame: 6 months

25-OH Vitamine D values will be collected for premature newborn , born before 32 weeks, or with a birth weight under 1500g.

A 25-OH Vitamine D blood value under 20µg/L is considered as a vitamine D deficiency
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vitamine D deficiency and maternal or feotal caracteristics
Time Frame: 6months
correlation between vitamine D deficiency and maternal or feotal caracteristics
6months
vitamine D deficiency and premature newborn comorbidities
Time Frame: 6 months
correlation between vitamine D deficiency and premature newborn comorbidities
6 months
effect of supplementation
Time Frame: 6months
Number (proportion) of children with normalized 25 OH vitamin D levels after Vitamine D supplementation according to neonatal department protocol.
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Hôpital Saint-Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

February 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PremaVitaD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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