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

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ClinicalTrials.gov Identifier: NCT02088359
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm Infants Other: Cycled light Other: Continue near darkness

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2014

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Feeding [ Time Frame: 0-1 month ]
    We evaluated full enteral feeding time between two groups.

  2. 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.



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Preterm infant (<32 gestational weeks) were enrolled in this study.
Criteria

Inclusion Criteria:

  • <32 gestational weeks preterm infants

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088359


Locations
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Turkey
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Turkey, 06230
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
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Responsible Party: Mehmet Yekta, Zekai Tahir Burak Maternity and Teaching Hospital, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02088359    
Other Study ID Numbers: ZTB000123
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: June 2012
Keywords provided by Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital:
cycled light, near darkness, growth
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications