Cycled Light and Crying of Preterm Infants

Sleep Clinical Trial

Official title:

Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513226
• Other study ID #: CH-160.7.002.920-3
• Status: Completed
• Phase: N/A
• First received: January 11, 2012
• Last updated: January 19, 2012
• Start date: June 2006
• Est. completion date: September 2008

Study information

• Verified date: January 2012
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Crying
• Sleep

Intervention

Other:
• Cycled light
lights on at daytime, lights off at nighttime

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Outcome

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