Sleep-wake Patterns in Preterm Infants

Completed

• Conditions: Sleep

• Registration Number: NCT04145362
• Lead Sponsor: Marmara University

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.

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 Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-27
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-30
• Study Start: 2019-11-18
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Last Update Submitted: 2021-09-19
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Marmara University School of Medicine; 🇹🇷 Istanbul, Turkey