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Cycled Light and Crying of Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01513226
First Posted: January 20, 2012
Last Update Posted: January 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Children's Hospital, Zurich
  Purpose
This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.

Condition Intervention
Crying Sleep Other: Cycled light

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants

Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • mean duration and change over time for total duration per 24 hours for crying variables [ Time Frame: 5 and 11 weeks corrected age ]

    mean duration per 24 hours for following variables: content, fussing, crying, unsoothable crying change over time, measured at 5 and 11 weeks corrected age

    measured by diary



Secondary Outcome Measures:
  • mean sleep duration per 24 hours and change over time [ Time Frame: 5,11 and 25 weeks corrected age ]
    mean sleep duration per 24 hours measured by sleep diary measured at 5, 11 and 25 weeks corrected age, for adressing change over time

  • mean weight gain per day [ Time Frame: during hospital stay ]
    mean weight gaing per day during hospital stay.

  • mean activity count per 24 hours and change over time [ Time Frame: 5, 11, and 25 weeks corrected age ]
    mean activity count per 24 hours measured by actigraph recordings measured at three time points, 5, 11 and 25 weeks corrected age to adress change over time


Enrollment: 37
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dim light
Day and nighttime dim light conditions
Other: Cycled light
lights on at daytime, lights off at nighttime

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • very preterm infants (≤ 32 0/7 weeks gestational age, GA)

Exclusion Criteria:

  • major cerebral injuries such as intraventricular haemorrhage grade III (according to Papile 16) or periventricular leukomalacia or venous infarction (according to Govaert and de Vries 17) diagnosed by cranial ultrasound
  • retinopathy of prematurity grade III and IV
  • congenital malformations
  • small for gestational age (birth weight < 3rd percentile)
  • prenatal infections
  • intrauterine drug exposure
  Contacts and Locations
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): NCT01513226


Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Oskar Jenni, MD Children's Hospital Zurich
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01513226     History of Changes
Other Study ID Numbers: CH-160.7.002.920-3
First Submitted: January 11, 2012
First Posted: January 20, 2012
Last Update Posted: January 20, 2012
Last Verified: January 2012

Keywords provided by University Children's Hospital, Zurich:
cycled light
dim light
circadian rhythm
actigraphy, sleep
premature infant