Neonatal HypocalcemiaNCT02147327
Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities
An observational study of Neonatal Hypocalcemia and Neonatal Sepsis, run by Zekai Tahir Burak Women's Health Research and Education Hospital.
Trial summary
Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system. Read more about this study
- Who is it for?
- Ages Up to 30 minutes
- Conditions the study is for
- Neonatal Hypocalcemia, Neonatal Sepsis
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 minutes
- All sexes
- No healthy volunteers
- Child
Study population: Newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital
Who may be able to join
- Term or preterm newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital
Who cannot join
- Preterm babies born before the 24. gestational week
- Babies with complex cardiac anomalies and/or dysmorphic features
About this study
Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system. For a long time, maternal low vitamin D level is a well known problem for our country and the level was reported as <10 ng/ml for 46-80% of mothers.The most prominent risk factor was determined as low socioeconomic status. Therefore, the level of 25-hydroxy-vitamin D is supposed to be in relation with several neonatal morbidities and maternal complications of pregnancy.
- Conditions
- Neonatal Hypocalcemia, Neonatal Sepsis
- Keywords
- vitamin D, cord blood, neonatal sepsis, neonatal morbidity
- Medical subject headings
- Neonatal Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
sepsis
Measured: 3 months but patients will be followed until discharge
feeding intolerance
Measured: 3 months but patients will be followed until discharge
hypocalcemia
Measured: 3 months but patients will be followed until discharge
bronchopulmonary dysplasia
Measured: 3 months but patients will be followed until discharge
patent ductus arteriosis
Measured: 3 months but patients will be followed until discharge
retinopathy of prematurity
Measured: 3 months but patients will be followed until discharge
maternal complications of pregnancy
Measured: from the beginning of gestation until birth process
Secondary outcomes (1)
rachitism
Measured: 4 months but patients will be followed until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HypocalcemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, birgul say, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147327
- Sponsor's protocol ID
- sevit25D3
- Status last verified
- May 2014
- First submitted
- 21 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cord Blood 25-hydroxy-vitamin D Level on Early Neonatal Morbidities
- ClinicalTrials.gov ID
- NCT02147327
- Acronym / sponsor ID
- sevit25D3
- Conditions
- Neonatal Hypocalcemia, Neonatal Sepsis
- Keywords
- vitamin D, cord blood, neonatal sepsis, neonatal morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cholecalciferol (vitamin D3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. This hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system. For a long time, maternal low vitamin D level is a well known problem for our country and the level was reported as <10 ng/ml for 46-80% of mothers.The most prominent risk factor was determined as low socioeconomic status. Therefore, the level of 25-hydroxy-vitamin D is supposed to be in relation with several neonatal morbidities and maternal complications of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 30 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital
Key inclusion criteria (1 listed)
- Term or preterm newborns which are hospitalized in the Neonatal Intensive Care Unit of our hospital
Key exclusion criteria (2 listed)
- Preterm babies born before the 24. gestational week
- Babies with complex cardiac anomalies and/or dysmorphic features
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sepsis
Time frame: 3 months but patients will be followed until discharge
feeding intolerance
Time frame: 3 months but patients will be followed until discharge
hypocalcemia
Time frame: 3 months but patients will be followed until discharge
bronchopulmonary dysplasia
Time frame: 3 months but patients will be followed until discharge
patent ductus arteriosis
Time frame: 3 months but patients will be followed until discharge
retinopathy of prematurity
Time frame: 3 months but patients will be followed until discharge
maternal complications of pregnancy
Time frame: from the beginning of gestation until birth process
1 secondary outcome
rachitism
Time frame: 4 months but patients will be followed until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hypocalcemia and Neonatal Sepsis, run by Zekai Tahir Burak Women's Health Research and Education Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sepsis (time frame: 3 months but patients will be followed until discharge). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.