Cycled Light and Crying of Preterm Infants
Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants
1 other identifier
interventional
37
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2006
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 11, 2012
CompletedFirst Posted
Study publicly available on registry
January 20, 2012
CompletedJanuary 20, 2012
January 1, 2012
1.6 years
January 11, 2012
January 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
mean sleep duration per 24 hours and change over time
5,11 and 25 weeks corrected age
mean weight gain per day
during hospital stay
mean activity count per 24 hours and change over time
5, 11, and 25 weeks corrected age
Study Arms (1)
Dim light
EXPERIMENTALDay and nighttime dim light conditions
Interventions
Eligibility Criteria
You may qualify if:
- very preterm infants (≤ 32 0/7 weeks gestational age, GA)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Guyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Very preterm infants show earlier emergence of 24-hour sleep-wake rhythms compared to term infants. Early Hum Dev. 2015 Jan;91(1):37-42. doi: 10.1016/j.earlhumdev.2014.11.002. Epub 2014 Nov 27.
PMID: 25460255DERIVEDGuyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Cycled light exposure reduces fussing and crying in very preterm infants. Pediatrics. 2012 Jul;130(1):e145-51. doi: 10.1542/peds.2011-2671. Epub 2012 Jun 11.
PMID: 22689866DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oskar Jenni, MD
Children's Hospital Zurich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2012
First Posted
January 20, 2012
Study Start
June 1, 2006
Primary Completion
January 1, 2008
Study Completion
September 1, 2008
Last Updated
January 20, 2012
Record last verified: 2012-01