Serum Folic Acid Levels in Preterm Infants (FALIPI)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital

ClinicalTrials.gov Identifier:

NCT01360528

First received: May 23, 2011

Last updated: February 15, 2012

Last verified: February 2011

History of Changes

Purpose

Therefore preterm infants must need folic acid replacement than term babies.

Condition
Very Low Birth Weight Baby


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Zekai Tahir Burak Maternity and Teaching Hospital

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Birth Weight

Drug Information available for: Folic acid Vitamin B Complex

U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:


Enrollment:	100
Study Start Date:	February 2011
Study Completion Date:	October 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

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.

Eligibility


Ages Eligible for Study:	24 Weeks to 34 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Extremely low birth weight, Very low birth weight, Low birth weight

Criteria

Inclusion Criteria:

-All preterm infants

Exclusion Criteria:

-Major congenital anomaly

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360528

Locations


Turkey
Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
Ankara, Turkey, 06600

Sponsors and Collaborators

Mehmet Yekta

More Information

No publications provided by Zekai Tahir Burak Women's Health Research and Education Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:	NCT01360528 History of Changes
Other Study ID Numbers:	ztb5326315185
Study First Received:	May 23, 2011
Last Updated:	February 15, 2012
Health Authority:	Turkey: Ministry of Health

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:


Folic acid replacement Folic acid Preterm neonate

Additional relevant MeSH terms:


Folic Acid Growth Substances Hematinics Hematologic Agents Micronutrients	Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Vitamin B Complex Vitamins

ClinicalTrials.gov processed this record on March 03, 2015

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