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Completed

NCT Number: NCT06880588

Sleep Characteristics in Late Premature Infants

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.

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Key information

Conditions

Late Preterm Infant Motor Development Sleep

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Brief Infant Sleep Questionnaire

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

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

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.

Primary outcomes

  1. Peabody Developmental Motor Scales | Second Edition

    Time frame: 6-12 months

    It is planned to use Peabody Motor Development Scale-2 to evaluate motor development. The test is designed to determine developmental delays in children between 0-72 months. It is used to evaluate the motor development of children with separate tests and rating scales for both gross motor skills and fine motor skills. Six subtests, reflexes, Stationary, Locomotion, Object Manipulation, Grasping, and Visual-Motor Integration, collectively measure a broad spectrum of motor functions including postural control, locomotor abilities, object manipulation, and hand-eye coordination. The subtests generate three composite scores: the Gross Motor Quotient, Fine Motor Quotient, and Total Motor Quotient, offering a comprehensive evaluation of a child's motor competence. Notably, higher scores on the Peabody Motor Development Scale-2 reflect superior motor performance, indicating better developmental outcomes.

  2. Test of Sensory Functions in Infants

    Time frame: 6-12 months

    It is used to determine whether a infant has a sensory processing problem and to what extent. It consists of 24 items. Test of sensory function in infants requires the baby to be stimulated and interacted with various materials. The total score varies between 0-49 and the test has norm values for different age groups. Although it is used from the fourth month onwards, the most reliable and valid results are obtained between 7-18 months.

  3. Brief Infant Sleep Questionnaire

    Time frame: 6-12 months

    The Brief Infant Sleep Questionnaire will be used to assess sleep. Infant sleep problems are among the most common problems presented to pediatricians. 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. Consists of 33 items, based on parent reports of infant or toddler sleep patterns, and used to validate data. Correlated with daily records and parent reports of sleep. Well-established for accuracy in documenting developmental sleep trends. In scoring, it is categorized as sleep duration, wakefulness duration, number of awakenings from sleep, presence of snoring, location of sleep.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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