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Cycled Light and Crying of Preterm Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01513226
First received: January 11, 2012
Last updated: January 19, 2012
Last verified: January 2012
History of Changes

January 11, 2012
January 19, 2012
June 2006
January 2008   (final data collection date for primary outcome measure)
mean duration and change over time for total duration per 24 hours for crying variables [ Time Frame: 5 and 11 weeks corrected age ] [ Designated as safety issue: No ]

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
Same as current
Complete list of historical versions of study NCT01513226 on ClinicalTrials.gov Archive Site
  • mean sleep duration per 24 hours and change over time [ Time Frame: 5,11 and 25 weeks corrected age ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Cycled Light and Crying of Preterm Infants
Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants

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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Crying
  • Sleep
Other: Cycled light
lights on at daytime, lights off at nighttime
Experimental: Dim light
Day and nighttime dim light conditions
Intervention: Other: Cycled light
Guyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Cycled light exposure reduces fussing and crying in very preterm infants. Pediatrics. 2012 Jul;130(1):e145-51. Epub 2012 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
September 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01513226
CH-160.7.002.920-3
No
University Children's Hospital, Zurich
University Children's Hospital, Zurich
Not Provided
Principal Investigator: Oskar Jenni, MD Children's Hospital Zurich
University Children's Hospital, Zurich
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP