Sleep Characteristics in Late Premature Infants

NCT ID: NCT06880588

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2025-06-01

Brief Summary

Studies examining sleep and developmental parameters in infants have primarily focused on either term or extremely preterm infants. However, a review of the existing literature reveals a lack of research investigating sleep characteristics and their relationship with motor and sensory development in late preterm infants. Therefore, the present study aims to evaluate sleep characteristics and explore their association with motor development and sensory processing in late preterm infants, who are at higher risk for developmental delays compared to term infants.

Detailed Description

Late preterm infants are defined as those born between 34 and 36 weeks and 6 days of gestational age. Although the medical literature places significant emphasis on extremely low birth weight and extremely preterm infants, late preterm infants are also at risk, with mortality rates three times higher than those of term infants. Born with lungs and brains that are not yet fully matured, late preterm infants may experience complications due to immaturity. Although they often appear healthier and more mature than they are, late preterm infants show significant differences from term infants (born between 37 and 42 weeks of gestation), particularly because their brain development has not yet been completed.

During the final weeks of gestation (34-40 weeks), critical developmental processes occur in the brain, including the formation of synaptic connections, myelination, and the development of cortical folds. Compared to normal term neonates, the late preterm brain appears 20% to 30% smaller, less developed, and less myelinated on magnetic resonance imaging. The sensory system is shaped immediately after birth by both the quantity and type of sensory experiences and continues to develop throughout life. In preterm infants, sensory processing has been associated with immaturity at birth, length of stay in the neonatal intensive care unit, white matter injury, and caregiver education.

Sleep is a critical factor for the healthy development of processes such as brain maturation, motor planning, postural control, and sensory integration, especially during infancy. Sleep is closely linked to brain development and infant behavior, and disruptions in sleep patterns can have profound and long-term effects on an infant's overall health, growth, and well-being in early life. Moreover, sleep plays a crucial role in the formation of persistent neural circuits necessary for early sensory development and the maturation of primary sensory systems in infants. The aim of this study is to investigate the relationship between sleep characteristics and motor development and sensory processing skills in late preterm infants (born between 34 weeks and 36 weeks + 6 days of gestation) who are between 6 and 12 months of corrected age. It is thought that sleep problems, which are frequently observed in preterm infants, may have significant effects on motor and sensory development. In this context, the primary objective of the study is to elucidate how sleep patterns and characteristics are associated with motor and sensory development in late preterm infants, and to provide scientific evidence to inform early intervention programs.

Conditions

Late Preterm Infant; Motor Development; Sleep

Study Design

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

Study Groups

Late preterm

Late preterm infants are defined as infants born between 34 and 36 (+6 days) weeks of gestation. Medical literature places great emphasis on extremely low birth weight and extremely preterm infants, but late preterm infants are also at risk and have mortality rates three times higher than those born full term.

Brief Infant Sleep Questionnaire

Intervention Type: BEHAVIORAL

The Brief Infant Sleep Questionnaire will be used to assess sleep. Infant sleep problems are among the most common problems presented to healthcare professionals. The extended version of the "Brief Infant Sleep Questionnaire" is a questionnaire developed by Sadeh to assess sleep problems and their causes in early childhood. This questionnaire has been translated into Turkish and assessed sleep environment and sleep problems in infants. It consists of 33 items, is based on parent reports of infant or toddler sleep patterns and is used to validate the data. It is associated with daily records and parent reports of sleep. Its sensitivity in documenting developmental sleep trends is well established

Test of Sensory Function in Infants

Intervention Type: BEHAVIORAL

It was planned to use the Test of Sensory Function in Infants to evaluate the sensory development of infants. Test of Sensory Function in Infants is frequently used to evaluate the sensory processing

Peabody Motor Development Scale-2

Intervention Type: BEHAVIORAL

It was planned to use the Peabody Motor Development Scale-2 to evaluate motor development. The Peabody Motor Development Scale-2 was designed to determine developmental delays in children aged 0-72 months.

Interventions

Brief Infant Sleep Questionnaire

The Brief Infant Sleep Questionnaire will be used to assess sleep. Infant sleep problems are among the most common problems presented to healthcare professionals. The extended version of the "Brief Infant Sleep Questionnaire" is a questionnaire developed by Sadeh to assess sleep problems and their causes in early childhood. This questionnaire has been translated into Turkish and assessed sleep environment and sleep problems in infants. It consists of 33 items, is based on parent reports of infant or toddler sleep patterns and is used to validate the data. It is associated with daily records and parent reports of sleep. Its sensitivity in documenting developmental sleep trends is well established

Intervention Type: BEHAVIORAL

Test of Sensory Function in Infants

It was planned to use the Test of Sensory Function in Infants to evaluate the sensory development of infants. Test of Sensory Function in Infants is frequently used to evaluate the sensory processing

Intervention Type: BEHAVIORAL

Peabody Motor Development Scale-2

It was planned to use the Peabody Motor Development Scale-2 to evaluate motor development. The Peabody Motor Development Scale-2 was designed to determine developmental delays in children aged 0-72 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Late preterm infants with a corrected age of 6-12 months,
• Infants with parental consent

Exclusion Criteria

• Infants with chromosomal abnormalities,
• having serious congenital problems,
• whose parents are unwilling to work,

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Rabia ZORLULAR

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rabia ZORLULAR

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Sadeh A, Mindell JA, Luedtke K, Wiegand B. Sleep and sleep ecology in the first 3 years: a web-based study. J Sleep Res. 2009 Mar;18(1):60-73. doi: 10.1111/j.1365-2869.2008.00699.x. Epub 2008 Oct 16.

Reference Type: BACKGROUND

PMID: 19021850 (View on PubMed)

DeGangi GA, Greenspan SI. The development of sensory functions in infants. Physical & Occupational Therapy in Pediatrics. 1989;8(4):21-33.

Reference Type: BACKGROUND

Young PC, Glasgow TS, Li X, Guest-Warnick G, Stoddard G. Mortality of late-preterm (near-term) newborns in Utah. Pediatrics. 2007 Mar;119(3):e659-65. doi: 10.1542/peds.2006-2486.

Reference Type: BACKGROUND

PMID: 17332185 (View on PubMed)

Medoff-Cooper B, Bakewell-Sachs S, Buus-Frank ME, Santa-Donato A; Near-Term Infant Advisory Panel. The AWHONN Near-Term Infant Initiative: a conceptual framework for optimizing health for near-term infants. J Obstet Gynecol Neonatal Nurs. 2005 Nov-Dec;34(6):666-71. doi: 10.1177/0884217505281873.

Reference Type: BACKGROUND

PMID: 16282223 (View on PubMed)

Zorlular R, Zorlular A, Elbasan B. Relationship between sleep characteristics, motor development, and sensory processing in late preterm infants. Sleep Med. 2025 Oct 13;136:106851. doi: 10.1016/j.sleep.2025.106851. Online ahead of print.

Reference Type: DERIVED

PMID: 41106044 (View on PubMed)

Other Identifiers

late premature and sleep

Identifier Type: -

Identifier Source: org_study_id