Compare of Effectiveness Cycled Light or Near Darkness on Growth Parameters in Preterm Infants

July 7, 2014 updated by: Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital
Infants are exposed to either continuous bright light continuous near darkness or unstructured combination of the two. The investigators primary objective is to determine the effectiveness cycled light and near darkness on growth in preterm infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Zekai Tahir Burak Maternity Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preterm infant (<32 gestational weeks) were enrolled in this study.

Description

Inclusion Criteria:

  • <32 gestational weeks preterm infants

Exclusion Criteria:

  • Major congenital anomaly
  • Small for gestation age
  • Grade III-IV intracranial hemorrhage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cycled light
Approximately 12 hours of light on and 12 hours of light off.
Other: Cycled light
We covered the incubator with blanket for darkness approximately 12 hours.
Near darkness
Continue near darkness
Other: Continue near darkness
We covered the incubator with blanket all days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness on growth
Time Frame: 3-12 months
We recorded infants' weight, height and head circumference measures on day 14, corrected 3 and 6 months.
3-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding
Time Frame: 0-1 month
We evaluated full enteral feeding time between two groups.
0-1 month
Ventilation support
Time Frame: 0-1 month
We evaluated duration of supplemental oxygen, nasal continuous positive airway pressure (CPAP) and mechanical ventilation for each groups.
0-1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZTB000123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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