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临床试验/NCT06111066
NCT06111066尚未招募不适用

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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
186
试验地点
1
主要终点
Maternal use of vitamin D supplements.

研究概览

简要总结

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 (30~50nmol/L), and sufficiency (>50~250nmol/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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Maternal use of vitamin D supplements.

时间窗: 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).

Maternal sunlight exposure.

时间窗: 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)

次要结局

  • Maternal education status.(2024.01-2029.12)
  • Maternal weight.(2024.01-2029.12)
  • Pregnancy complications.(2024.01-2029.12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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