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NCT04145362

Sleep-wake Patterns in Preterm Infants

Completed Last updated 21 September 2021
What this trial tests

trial in Sleep in 20 participants. Completed in 1 June 2020.

Timeline
18 November 2019
Primary endpoint
1 June 2020
1 June 2020

Quick facts

Lead sponsorMarmara University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment20
Start date18 November 2019
Primary completion1 June 2020
Estimated completion1 June 2020
Sites1 location across Turkey (Türkiye)

Conditions studied

Sponsor

Marmara University

Who can join

Adults 28 Weeks to 37 Weeks, any sex, with Sleep. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The development of sleep-wake behavior is considered to be one of the most important maturation processes occurring in the first year of life. Sleep-wake behavior is related to neurobehavioral regulation of the infant and cognitive function, and gives important information about infant's health. It is suggested that the identification of sleep-wake patterns in preterm infants is critical to the detection of future disorders, early diagnosis and planning of intervention studies In this study we aimed to recruit a total of 25 premature babies born between 28 to 37 weeks of gestational age over six month in the Neonatal Intensive Care Unit of Marmara University Pendik Training and Research Hospital. Sleep wake cycles of these premature infants will be assessed at 32 weeks corrected age by actigraphy, sleep diaries, direct observation and Amplitude integrated electroencephalography (aEEG). We also aimed to investigate the maturation of sleep patterns of these infants included in the study at postconceptional 40th weeks of age, and 12th, and at 24th weeks corrected age, by sleep diaries and actigraphic measurements at their home environment. Development will be assessed by Bayley and Ages and Stages Questionnaire.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Sleep assessment in preterm infants: Use of actigraphy and aEEG.
    Ülgen Ö, Barış HE, Aşkan ÖÖ, Akdere SK, et al · · 2023 · cited 6× · PMID 36459917 · DOI 10.1016/j.sleep.2022.11.020

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Other recruiting trials for Sleep

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