NCT01360528

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2011

Enrollment Period

3 months

First QC Date

May 23, 2011

Last Update Submit

February 15, 2012

Conditions

Very Low Birth Weight Baby

Keywords

Folic acid replacementFolic acidPreterm neonate

Study Arms (3)

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

Eligibility Criteria

Age24 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All preterm infants

You may not qualify if:

  • Major congenital anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit

Ankara, 06600, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 24051483DERIVED

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Zekai Tahir Burak Maternity and Teaching Hospital

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 25, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2011

Study Completion

October 1, 2011

Last Updated

February 17, 2012

Record last verified: 2011-02

Locations

TU(1)