Very Low Birth Weight BabyFALIPINCT01360528
Serum Folic Acid Levels in Preterm Infants
An observational study of Very Low Birth Weight Baby, run by Mehmet Yekta at 1 site in Turkey (Türkiye).
Trial summary
Therefore preterm infants must need folic acid replacement than term babies. Read more about this study
- Who is it for?
- Ages 24 to 34 weeks
- Conditions the study is for
- Very Low Birth Weight Baby
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2011to Oct 2011
- 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 24 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Extremely low birth weight, Very low birth weight, Low birth weight
Who may be able to join
- -All preterm infants
Who cannot join
- -Major congenital anomaly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
Ankara, 06600
About this study
Official title: Zekai Tahir Burak Maternity and Teaching Hospital
Therefore preterm infants must need folic acid replacement than term babies.
Read the detailed description
All babies need to different vitamin supplementation. Especially preterm infants need some vitamin supplements. Folic acid is very important structure of part of cell growing.ın theorically; preterm infants have very rapid cell reproduction capacity than term infants. Therefore preterm infants must need folic acid replacement than term babies. The investigators want to determine preterm infants folic acid levels due to gestational age whether needs folic acid replacement.
- Conditions
- Very Low Birth Weight Baby
- Keywords
- Folic acid replacement, Folic acid, Preterm neonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Extremely low birth weight | Extremely low birth weight under 1000 gram | |
| Very low birth weight | Between 1000-1500 gram babies | |
| Low birth weight | Between 1500-2500 gram |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight BabyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Yekta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360528
- Sponsor's protocol ID
- ztb5326315185
- Acronym
- FALIPI
- Status last verified
- Feb 2011
- First submitted
- 23 May 2011
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Oncel MY, Calisici E, Ozdemir R, Yurttutan S, Erdeve O, Karahan S, Dilmen U. Is folic acid supplementation really necessary in preterm infants </= 32 weeks of gestation? J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):188-92. doi: 10.1097/MPG.0000000000000181.
PubMed 24051483
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zekai Tahir Burak Maternity and Teaching Hospital
- ClinicalTrials.gov ID
- NCT01360528
- Acronym / sponsor ID
- FALIPI / ztb5326315185
- Conditions
- Very Low Birth Weight Baby
- Keywords
- Folic acid replacement, Folic acid, Preterm neonate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mehmet YektaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 May 2011 (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.
Therefore preterm infants must need folic acid replacement than term babies.
Detailed description
All babies need to different vitamin supplementation. Especially preterm infants need some vitamin supplements. Folic acid is very important structure of part of cell growing.ın theorically; preterm infants have very rapid cell reproduction capacity than term infants. Therefore preterm infants must need folic acid replacement than term babies. The investigators want to determine preterm infants folic acid levels due to gestational age whether needs folic acid replacement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extremely low birth weight | – | –Extremely low birth weight under 1000 gram |
| Very low birth weight | – | –Between 1000-1500 gram babies |
| Low birth weight | – | –Between 1500-2500 gram |
Who may qualify
- Ages
- 24 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Extremely low birth weight, Very low birth weight, Low birth weight
Key inclusion criteria (1 listed)
- -All preterm infants
Key exclusion criteria (1 listed)
- -Major congenital anomaly
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
Not reported in the source record.
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 17 Feb 2012.
- Derived from this study: PubMed 24051483Oncel MY, Calisici E, Ozdemir R, Yurttutan S, Erdeve O, Karahan S, Dilmen U. Is folic acid supplementation really necessary in preterm infants </= 32 weeks of gestation? J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):188-92. doi: 10.1097/MPG.0000000000000181.
Related trials for Very Low Birth Weight Baby
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruiting
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Premature Infant, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Not yet recruiting
A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns
Prematurity; Extreme
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Very Low Birth Weight Baby, run by Mehmet Yekta at 1 site in Turkey (Türkiye).
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 1 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 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01360528, which also lists 1 linked publication.
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 17 Feb 2012.