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
  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: 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 ] [ 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



Secondary Outcome Measures:
  • 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


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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513226

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

No publications provided by University Children's Hospital, Zurich

Additional 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
Study First Received: January 11, 2012
Last Updated: January 19, 2012
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on September 18, 2014