Sleep Clinical Trial
Official title:
Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants
Verified date | January 2012 |
Source | University Children's Hospital, Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | September 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Children's Hospital, Zurich |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mean duration and change over time for total duration per 24 hours for crying variables | 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 |
5 and 11 weeks corrected age | No |
Secondary | mean sleep duration per 24 hours and change over time | mean sleep duration per 24 hours measured by sleep diary measured at 5, 11 and 25 weeks corrected age, for adressing change over time | 5,11 and 25 weeks corrected age | No |
Secondary | mean weight gain per day | mean weight gaing per day during hospital stay. | during hospital stay | No |
Secondary | mean activity count per 24 hours and change over time | 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 | 5, 11, and 25 weeks corrected age | No |
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