Sleep-wake Patterns in Preterm Infants

NCT04145362 | Completed

• 1 other identifier: SAG-C-TUP-131217-0647
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

preterm; actigraphy; sleep

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

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

  corrected age 6 months

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

  corrected age 6 months

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm infants born between 28 to 37 weeks of gestational age

You may qualify if:

• Being preterm admitted to Neonatal Intensive Care Unit
• Gestational age must be between 28 to 37 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36459917 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: October 30, 2019
• Study Start: November 18, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 21, 2021

Record last verified: 2019-10

Locations

TU (1)