NCT01299428

Brief Summary

The aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry (NIRS) at the hypernatremic dehydration in newborns.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 18, 2011

Status Verified

February 1, 2011

Enrollment Period

3 months

First QC Date

February 17, 2011

Last Update Submit

February 17, 2011

Conditions

HYPERNATREMIA

Keywords

CEREBRAL OXYGENATIONHYPERNATREMİANEWBORNNA VALUES

Outcome Measures

Primary Outcomes (1)

  • CEREBRAL OXYGENATION

    NIRS METHODS

    3 MONTHS

Secondary Outcomes (1)

  • NEURODEVELOPMENT

    12-18 MONTHS

Study Arms (1)

cerebral oxygenation

ACTIVE COMPARATOR
Device: INVOS 5100

Interventions

INVOS 5100DEVICE

INVOS 5100 IS AN EQUIPMENT THAT MEASURED CEREBRAL OXYGENATION WITH NEAR INFRARED SPECTROPHOTOMETRY METHOD.

cerebral oxygenation

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • gestation week \> 37 ve Na \>150 mg/dl
  • Dehydration

You may not qualify if:

  • Sepsis
  • Intracranial Haemorrhagia
  • Congenital Cardiac Diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Samanpazarı, 06460, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypernatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

melek akar, M.D

CONTACT

+905052550518melek_akar@yahoo.com.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 18, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2011

Study Completion

August 1, 2011

Last Updated

February 18, 2011

Record last verified: 2011-02

Locations

TU(1)