Cycled Light and Crying of Preterm Infants

January 19, 2012 updated by: University Children's Hospital, Zurich

Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dim light
Day and nighttime dim light conditions
Other: Cycled light
lights on at daytime, lights off at nighttime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean duration and change over time for total duration per 24 hours for crying variables
Time Frame: 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
5 and 11 weeks corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean sleep duration per 24 hours and change over time
Time Frame: 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
5,11 and 25 weeks corrected age
mean weight gain per day
Time Frame: during hospital stay
mean weight gaing per day during hospital stay.
during hospital stay
mean activity count per 24 hours and change over time
Time Frame: 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
5, 11, and 25 weeks corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Oskar Jenni, MD, Children's Hospital Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CH-160.7.002.920-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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