Clinical Trials Directory

Trials / Completed

CompletedNCT06880588

Sleep Characteristics in Late Premature Infants

Relationship Between Sleep Characteristics and Motor Development and Sensory Processing Skills in Late Premature Infants

Status
Completed
Phase
Study type
Observational
Enrollment
81 (actual)
Sponsor
Gazi University · Academic / Other
Sex
All
Age
6 Months – 12 Months
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALBrief Infant Sleep QuestionnaireThe 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
BEHAVIORALTest of Sensory Function in InfantsIt 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
BEHAVIORALPeabody Motor Development Scale-2It 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.

Timeline

Start date
2025-03-19
Primary completion
2025-06-01
Completion
2025-06-01
First posted
2025-03-17
Last updated
2025-06-25

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06880588. Inclusion in this directory is not an endorsement.