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Completed

NCT Number: NCT04145362

Sleep-wake Patterns in Preterm Infants

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.

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Key information

Conditions

Sleep Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

28 week–37 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Sleep architecture in preterm infants during their stay in Newborn Intensive Care Unit

    Time frame: 1 day of assessment

    Preterm infant's sleep wake patterns will be described by using actigraphy, aEEG, and video recorded direct observation

  2. Preterm infant's sleep wake patterns will be described at 12, and 24 weeks of corrected age

    Time frame: 6 months corrected age

    Preterm infant's sleep wake patterns will be described at 12, and 24 weeks of corrected age by actigraphy, and sleep diaries

Secondary outcomes

  1. Neurodevelopmental assessment using the Bayley Scales of Infant and Toddler development (Third Edition)

    Time frame: corrected age 6 months

    Bayley Scales of Infant and Toddler development (Third Edition) will be used for neurodevelopment assessment at 12, and 24 weeks of corrected age

  2. Developmental screening using the Ages and Stages Questionnaire (ASQ-2)

    Time frame: corrected age 6 months

    Ages and Stages Questionnaire (ASQ-2) is parent-completed questionnaire that will be used as a general developmental screening tool

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Assessment of Factors Affecting Sleep-Wake Patterns in Preterm Infants by Actigraphy, Amplitude Integrated Electroencephalography (aEEG), Sleep Diaries and Direct Observation

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2019
Registry last updated
Sep 21, 2021

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

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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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