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

NCT ID: NCT06111066

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2029-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vitamin d Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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vitamin D deficiency

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

No interventions assigned to this group

vitamin D insufficiency

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

No interventions assigned to this group

vitamin D sufficiency

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ouyang Ying, Prof.

Role: STUDY_DIRECTOR

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

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Ouyang Ying, Prof.

Role: CONTACT

+86 13925131189

Xie Xinyi, BS

Role: CONTACT

+86 15636110916

Facility Contacts

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Ouyang Ying, Prof.

Role: primary

+86 13925131189

Other Identifiers

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SYSKY-2023-900-01

Identifier Type: -

Identifier Source: org_study_id

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