CClinicalTrials.gg
Status unknownNCT01299428Updated Feb 18, 2011

Evaluation of the Cerebral Oxygenation With Near Infrared Spectrophotometry (NIRS) at the Hypernatremic Dehydration in Newborn

An interventional study of INVOS 5100 in HYPERNATREMIA, sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital. Status unknown at 1 site in Turkey. Open to participants aged 1 Day to 1 Month. Per ClinicalTrials.gov, last updated 2011-02-18.

Sponsored by Zekai Tahir Burak Women's Health Research and Education Hospital · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
1 Day to 1 Month
Sex
All
01

Study summary

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

02

Conditions studied

  • HYPERNATREMIA

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Keywords

  • CEREBRAL OXYGENATION
  • HYPERNATREMİA
  • NEWBORN
  • NA VALUES
03

Who can participate

Ages eligible
1 Day to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Sepsis
  • Intracranial Haemorrhagia
  • Congenital Cardiac Diseases
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (estimated)

Study arms

  • Active comparator
    cerebral oxygenation

    Device: INVOS 5100

Interventions

  • DeviceINVOS 5100

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

05

What researchers measure

Primary outcomes

  1. CEREBRAL OXYGENATION

    NIRS METHODS

    Time frame: 3 MONTHS

Secondary outcomes

  1. NEURODEVELOPMENT

    NEURODEVELOPMENT EVALUATION

    Time frame: 12-18 MONTHS

06

Study locations

1 of 1 sites recruiting
  • Zekai Tahir Burak Maternity Teaching Hospital
    Ankara, Samanpazarı 06460, Turkey
    Recruiting
07

Registry details

Key details

Study ID
NCT01299428
Lead sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
First posted
Feb 18, 2011
Start date
Feb 2011
Primary completion
May 2011 (estimated)
Completion
Aug 2011 (estimated)
Last update
Feb 18, 2011

Study contacts

melek akar, M.D
Contact
melek_akar@yahoo.com.tr
+905052550518

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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