Sleep-wake Patterns in Preterm Infants

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145362
• Other study ID #: SAG-C-TUP-131217-0647
• Status: Completed
• Start date: November 18, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: October 2019
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Sleep

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep architecture in preterm infants during their stay in Newborn Intensive Care Unit	Preterm infant's sleep wake patterns will be described by using actigraphy, aEEG, and video recorded direct observation	1 day of assessment
Primary	Preterm infant's sleep wake patterns will be described at 12, and 24 weeks of corrected age	Preterm infant's sleep wake patterns will be described at 12, and 24 weeks of corrected age by actigraphy, and sleep diaries	6 months corrected age
Secondary	Neurodevelopmental assessment using the Bayley Scales of Infant and Toddler development (Third Edition)	Bayley Scales of Infant and Toddler development (Third Edition) will be used for neurodevelopment assessment at 12, and 24 weeks of corrected age	corrected age 6 months
Secondary	Developmental screening using the Ages and Stages Questionnaire (ASQ-2)	Ages and Stages Questionnaire (ASQ-2) is parent-completed questionnaire that will be used as a general developmental screening tool	corrected age 6 months