- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06880588
Sleep Characteristics in Late Premature Infants
Relationship Between Sleep Characteristics and Motor Development and Sensory Processing Skills in Late Premature Infants
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Gazi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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,
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6-12 months
|
|
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.
|
6-12 months
|
|
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.
|
6-12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabia ZORLULAR, Gazi University
Publications and helpful links
General Publications
- 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.
- DeGangi GA, Greenspan SI. The development of sensory functions in infants. Physical & Occupational Therapy in Pediatrics. 1989;8(4):21-33.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- late premature and sleep
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionCompleted
-
Mahidol UniversityRamathibodi HospitalNot yet recruitingSleep Inertia | Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization | Night Shift WorkThailand
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Universidade Federal de PernambucoEnrolling by invitationSleep | Obstructive Sleep Apnea (OSA)Brazil
-
Atlas UniversityCompletedSleep | Surgery | Sleep QualityTurkey (Türkiye)
-
Mersin UniversityCompletedSleep Quality | Sleep PerceptionTurkey (Türkiye)
-
Brigham and Women's HospitalNot yet recruitingObstructive Sleep Apnea | Sleep-disordered BreathingUnited States
-
Institute of Nutrition, Slovenia (Nutris)Valens Int. d.o.o., Slovenija; Faculty of Pharmacy, University of Ljubljana... and other collaboratorsNot yet recruitingSleep Quality | Sleep Onset LatencySlovenia
Clinical Trials on Brief Infant Sleep Questionnaire
-
Nigde Omer Halisdemir UniversityCompletedSleep | Infant | Joint Hypermobility SyndromeTurkey (Türkiye)
-
Marmara UniversityCompletedEmotional Disorder of ChildhoodTurkey
-
Chung Shan Medical UniversityCompleted
-
Nigde Omer Halisdemir UniversityCompletedSleep | Motor Development | Colic, Infantile | Sensory Integration DysfunctionTurkey
-
Penn State UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedSleep | Parent-Child Relations | Parenting | Marital RelationshipUnited States
-
University of TorontoCompletedBreastfeeding | Breastfeeding, Exclusive | Vulnerable Population | Complementary Feeding | Infant Nutrition | Food SecurityCanada
-
Massachusetts General HospitalAmerican Foundation for Suicide PreventionCompletedBipolar Disorder | Sleep Problems | Suicidal ThoughtsUnited States
-
Karabuk UniversityZonguldak Bulent Ecevit UniversityNot yet recruitingSelf Efficacy | Sleep Hygiene | Infant Sleeping Habits | Parent EducationTurkey (Türkiye)
-
Beth Israel Deaconess Medical CenterCompletedIrritable Bowel Syndrome | Sleep DisturbanceUnited States