Sleep-wake Patterns in Preterm Infants

NCT ID: NCT04145362

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2020-06-01

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.

Conditions

Sleep

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Perran Boran

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marmara University School of Medicine

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Ulgen O, Baris HE, Askan OO, Akdere SK, Ilgin C, Ozdemir H, Bekiroglu N, Gucuyener K, Ozek E, Boran P. Sleep assessment in preterm infants: Use of actigraphy and aEEG. Sleep Med. 2023 Jan;101:260-268. doi: 10.1016/j.sleep.2022.11.020. Epub 2022 Nov 20.

Reference Type: DERIVED

PMID: 36459917 (View on PubMed)

Other Identifiers

SAG-C-TUP-131217-0647

Identifier Type: -

Identifier Source: org_study_id