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Completed

NCT Number: NCT01513226

Cycled Light and Crying of 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.

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Key information

Conditions

Crying Behavior Communication Female Urogenital Diseases and Pregnancy Complications Nonverbal Communication Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Sleep Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cycled Light

Other

lights on at daytime, lights off at nighttime

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. mean weight gain per day

    Time frame: during hospital stay

    mean weight gaing per day during hospital stay.

  3. 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

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 20, 2012
Registry last updated
Jan 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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