Vitamin D Levels in Neonatal Umbilical Cord Blood: Factors and Prognostic Analysis

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06111066
Collaborator
(none)
186
1
72
2.6

Study Details

Study Description

Brief Summary

This study is a retrospective-prospective cohort study that investigates the factors influencing neonatal umbilical cord blood 25(OH)D levels, and the impact of exposure to low intrauterine 25(OH)D levels on neonatal prognosis. Newborns born in Sun Yat-sen Memorial Hospital of Sun Yat-sen University from August 2023 to August 2024 were selected. 2ml of umbilical cord blood was collected to test serum 25(OH)D levels. Based on the umbilical cord blood 25(OH)D levels, newborns were divided into three groups: vitamin D deficiency (<30nmol/L), insufficiency (3050nmol/L), and sufficiency (>50250nmol/L). Factors influencing neonatal vitamin D levels at birth were investigated by reviewing medical records, questionnaire collection, phone interviews, etc., collecting data on basic neonatal information, maternal information, complications during pregnancy, prenatal biochemical test results, medication history during pregnancy, lifestyle habits during pregnancy, and vitamin D supplementation status. Phone follow-ups on the health of the newborns during their hospital stay and at 1 month and 2 months after discharge were conducted to investigate the impact of exposure to low intrauterine 25(OH)D levels on neonatal prognosis, providing a theoretical basis for early intervention in high-risk pregnant women and early identification of high-risk groups with vitamin D deficiency or insufficiency among newborns.

Miscarriages prevention is a major feature of our hospital's obstetrics department. Many pregnant women who are hospitalized and give birth at our hospital have a history of fetus protection. Choosing pregnant women and newborns from our hospital's obstetrics department as research subjects is conducive to exploring the impact of specific diseases and medication histories on neonatal vitamin D deficiency, which is an innovative aspect of this study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    186 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Vitamin D Levels in Neonatal Umbilical Cord Blood: Factors and Prognostic Analysis
    Anticipated Study Start Date :
    Jan 1, 2024
    Anticipated Primary Completion Date :
    Jan 1, 2026
    Anticipated Study Completion Date :
    Dec 30, 2029

    Arms and Interventions

    Arm Intervention/Treatment
    vitamin D deficiency

    The umbilical cord blood 25(OH)D levels: <30nmol/L

    vitamin D insufficiency

    The umbilical cord blood 25(OH)D levels: 30~50nmol/L

    vitamin D sufficiency

    The umbilical cord blood 25(OH)D levels: >50~250nmol/L

    Outcome Measures

    Primary Outcome Measures

    1. Maternal use of vitamin D supplements. [2024.01-2029.12]

      Investigating the situation of mothers taking vitamin D supplements during pregnancy through questionnaires and telephone interviews. This includes when they started taking them during pregnancy(weeks of gestation), the frequency of consumption(how many days a week), and the dosage taken each time(IU).

    2. Maternal sunlight exposure. [2024.01-2029.12]

      Investigating the conditions of sunlight exposure during pregnancy through questionnaires and telephone interviews. Including ethnicity, skin color, long-term residence during pregnancy, outdoor activity time (how many hours per day), and whether sun protection measures are used when going out (such as sunscreen, umbrellas, clothing)

    Secondary Outcome Measures

    1. Maternal education status. [2024.01-2029.12]

      Education levels are divided into two categories based on the highest level of education attained. The first category is 'below bachelor's degree,' which includes no formal education, elementary school, junior high school, high school, and vocational/technical education. The second category is 'bachelor's degree and above,' which includes bachelor's degrees, master's degrees, and doctoral degrees.

    2. Maternal weight. [2024.01-2029.12]

      Calculated by maternal pre-pregnancy BMI, referring to the weight (kg) within one week before delivery, divided by the square of height (m). And the maternal weight gain during pregnancy (kg).

    3. Pregnancy complications. [2024.01-2029.12]

      Pregnancy complications refer to health problems that occur during pregnancy. Including gestational diabetes, hypertensive disease in pregnancy, preeclampsia, intrauterine growth restriction (IUGR), and so on.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Newborns delivered in Sun Yat-sen Memorial Hospital's obstetrics department.

    • Relatives agree to use clinically discarded specimens for research and have signed a consent form.

    Exclusion Criteria:
    • Newborns with genetic mutations or congenital malformations.

    • Patients who died before discharge.

    • Pregnant women with conditions like chylous diarrhea, inflammatory bowel disease, and other chronic digestive system diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong China 510520

    Sponsors and Collaborators

    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Investigators

    • Study Director: Ouyang Ying, Prof., Sun Yat-sen Memorial Hospital,Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT06111066
    Other Study ID Numbers:
    • SYSKY-2023-900-01
    First Posted:
    Nov 1, 2023
    Last Update Posted:
    Nov 1, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 1, 2023