Completed

Is Higher Cord Blood 25(Oh)-Vitamin D Level Preventive For Any Morbidity Including Rds, Pda, Nec, Bpd And Rop In Preterm Infants

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+13

+ Female Urogenital Diseases and Pregnancy Complications

+ Infections

+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2012
See protocol details

Summary

Principal SponsorDr. Sami Ulus Children's Hospital
Last updated: August 15, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

It was shown that vitamin D play important role in the pathogenesis of long term morbidities of newborn. Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. The aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.

NCT01812681
Principal SponsorDr. Sami Ulus Children's Hospital
Last updated: August 15, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

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

81 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsInfectionsInflammationObstetric Labor ComplicationsObstetric Labor, PrematureLung DiseasesPathologic ProcessesPregnancy ComplicationsRespiration DisordersRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeRespiratory Distress SyndromeSepsisPremature Birth

Criteria

1 inclusion criteria required to participate
infants < 32 weeks of gestational age
2 exclusion criteria prevent from participating
infants > 32 weeks of gestational age
infants with major congenital abnormality

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Sami Ulus CH

Ankara, Turkey (Türkiye)Open Sami Ulus CH in Google Maps
CompletedOne Study Center