- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04145362
Sleep-wake Patterns in Preterm Infants
Assessment of Factors Affecting Sleep-Wake Patterns in Preterm Infants by Actigraphy, Amplitude Integrated Electroencephalography (aEEG), Sleep Diaries and Direct Observation
Study Overview
Status
Conditions
Detailed Description
Studies show that the patterns of sleep-wakefulness reflect the maturation of the central nervous system in preterm infants and are indicative of behavioral development. It is emphasized 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.
The primary objective of this study is to assess factors affecting the maturation of sleep wake cycles in preterm infants by actigraphy, sleep diaries, direct observation, and aEEG. Our secondary objectives were to assess the neurodevelopment of these infants.
In this study we aimed to recruit a total of 25 premature babies born between 28 to 37 weeks of gestational age over a six month period in the Neonatal Intensive Care Unit of Marmara University Pendik Training and Research Hospital. Sleep architecture will be assessed at 32 corrected age by actigraphy, sleep diaries, and aEEG. Simultaneous video recording and direct observation will be performed and sleep stages will be defined. Anderson Behavioral State Scale will also be applied. Philips Respironics Actiwatch-2 devices will be used. The follow up will be at post conceptional 40 weeks, 12 and 24 weeks corrected age. Development will be assessed by Bayley test and Ages and Stages Questionnaire.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Marmara University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being preterm admitted to Neonatal Intensive Care Unit
- Gestational age must be between 28 to 37 weeks
Exclusion Criteria:
- Preterm still receiving invasive mechanical ventilation at the time of data collection,
- Major congenital anomalies,
- Critically ill babies (sepsis),
- Major cerebral injuries (intraventricular hemorrhage grade III, and IV, periventricular leukomalacia)
- Retinopathy of prematurity grade III and IV,
- Necrotizing enterocolitis
- Infants using sedative or anticonvulsant drugs
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep architecture in preterm infants during their stay in Newborn Intensive Care Unit
Time Frame: 1 day of assessment
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Preterm infant's sleep wake patterns will be described by using actigraphy, aEEG, and video recorded direct observation
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1 day of assessment
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Preterm infant's sleep wake patterns will be described at 12, and 24 weeks of corrected age
Time Frame: 6 months corrected age
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Preterm infant's sleep wake patterns will be described at 12, and 24 weeks of corrected age by actigraphy, and sleep diaries
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6 months corrected age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurodevelopmental assessment using the Bayley Scales of Infant and Toddler development (Third Edition)
Time Frame: corrected age 6 months
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Bayley Scales of Infant and Toddler development (Third Edition) will be used for neurodevelopment assessment at 12, and 24 weeks of corrected age
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corrected age 6 months
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Developmental screening using the Ages and Stages Questionnaire (ASQ-2)
Time Frame: corrected age 6 months
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Ages and Stages Questionnaire (ASQ-2) is parent-completed questionnaire that will be used as a general developmental screening tool
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corrected age 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAG-C-TUP-131217-0647
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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