Cycled Light and Crying of Preterm Infants

Not Applicable

Completed

• Conditions: Crying; Sleep
• Interventions: Other: Cycled light

• Registration Number: NCT01513226
• Lead Sponsor: University Children's Hospital, Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-01
• Study Completion: 2008-09
• Status Verified: 2012-01
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-19
• Last Update Submitted: 2012-01-19
• Study First Posted: 2012-01-20
• Last Update Posted: 2012-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dim light	Cycled light	Day and nighttime dim light conditions

Primary Outcome Measures

Name	Time	Method
mean duration and change over time for total duration per 24 hours for crying variables	5 and 11 weeks corrected age	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

Name	Time	Method
mean activity count per 24 hours and change over time	5, 11, and 25 weeks corrected age	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
mean sleep duration per 24 hours and change over time	5,11 and 25 weeks corrected age	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	during hospital stay	mean weight gaing per day during hospital stay.