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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
  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

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

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
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 May 19, 2013