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

NCT06111066 | Not Yet Recruiting

• 1 other identifier: SYSKY-2023-900-01
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Vitamin d Deficiency

Keywords

vitamin D; neonatal umbilical cord blood; influence factors; prognosis

Outcome Measures

Primary Outcomes (2)

• Maternal use of vitamin D supplements.

  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).

  2024.01-2029.12

• Maternal sunlight exposure.

  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)

  2024.01-2029.12

Secondary Outcomes (3)

• Maternal education status.

  2024.01-2029.12

• Maternal weight.

  2024.01-2029.12

• Pregnancy complications.

  2024.01-2029.12

Study Arms (3)

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

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Selected newborns and their mothers who were born at Sun Yat-sen Memorial Hospital of Sun Yat-sen University starting from September 2023.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510520, China

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ouyang Ying, Prof.

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

  STUDY DIRECTOR

Central Study Contacts

Ouyang Ying, Prof.

CONTACT

+86 13925131189; ouyy@mail.sysu.edu.cn

Xie Xinyi, BS

CONTACT

+86 15636110916; tsesumyee1997@163.com

Study Design

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

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: November 1, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 30, 2029
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)