Sleep-wake Patterns in Preterm Infants

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT04145362
Collaborator
(none)
20
1
6.4
3.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Factors Affecting Sleep-Wake Patterns in Preterm Infants by Actigraphy, Amplitude Integrated Electroencephalography (aEEG), Sleep Diaries and Direct Observation
    Actual Study Start Date :
    Nov 18, 2019
    Actual Primary Completion Date :
    Jun 1, 2020
    Actual Study Completion Date :
    Jun 1, 2020

    Outcome Measures

    Primary Outcome Measures

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

    1. Neurodevelopmental assessment using the Bayley Scales of Infant and Toddler development (Third Edition) [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) [corrected age 6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    28 Weeks to 37 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marmara University School of Medicine Istanbul Turkey

    Sponsors and Collaborators

    • Marmara University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Perran Boran, Professor of Pediatrics, Marmara University
    ClinicalTrials.gov Identifier:
    NCT04145362
    Other Study ID Numbers:
    • SAG-C-TUP-131217-0647
    First Posted:
    Oct 30, 2019
    Last Update Posted:
    Sep 21, 2021
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Perran Boran, Professor of Pediatrics, Marmara University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2021