Late Preterm InfantNCT06880588
Sleep Characteristics in Late Premature Infants
An observational study of Late Preterm Infant and Motor Development, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Late Preterm Infant, Motor Development, Sleep
- What is being tested?
- Brief Infant Sleep Questionnaire, Test of Sensory Function in Infants and Peabody Motor Development Scale-2
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2025to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: The study group will consist of late premature babies (34-36 weeks) and their families whose corrected gestational age is between 6-12 months and whose parents' consent has been obtained.
Who may be able to join
- Late preterm infants with a corrected age of 6-12 months,
- Infants with parental consent
Who cannot join
- Infants with chromosomal abnormalities,
- having serious congenital problems,
- whose parents are unwilling to work,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Sleep Characteristics and Motor Development and Sensory Processing Skills 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.
Read the 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
- Being tested
- Brief Infant Sleep Questionnaire, Test of Sensory Function in Infants, Peabody Motor Development Scale-2
- Keywords
- Sleep, late preterm, motor development, sensory processing skill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Infant Sleep QuestionnaireBehavioural
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 InfantsBehavioural
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-2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Brief Infant Sleep Questionnaire; Behavioral: Test of Sensory Function in Infants; Behavioral: Peabody Motor Development Scale-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peabody Developmental Motor Scales | Second Edition
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.
Measured: 6-12 months
Test of Sensory Functions in Infants
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.
Measured: 6-12 months
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 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.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start19 Mar 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Late Preterm InfantStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ZORLULAR, Gazi University
- Investigators
- Rabia ZORLULAR, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880588
- Sponsor's protocol ID
- late premature and sleep
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19021850DeGangi 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.
PubMed 17332185Medoff-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.
PubMed 16282223Zorlular R, Zorlular A, Elbasan B. Relationship between sleep characteristics, motor development, and sensory processing in late preterm infants. Sleep Med. 2025 Dec;136:106851. doi: 10.1016/j.sleep.2025.106851. Epub 2025 Oct 13.
PubMed 41106044
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Sleep Characteristics and Motor Development and Sensory Processing Skills in Late Premature Infants
- ClinicalTrials.gov ID
- NCT06880588
- Acronym / sponsor ID
- late premature and sleep
- Conditions
- Late Preterm Infant, Motor Development, Sleep
- Keywords
- Sleep, late preterm, motor development, sensory processing skill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Late preterm | – | Behavioral: Brief Infant Sleep Questionnaire, Behavioral: Test of Sensory Function in Infants, Behavioral: Peabody Motor Development Scale-2Late 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. |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study group will consist of late premature babies (34-36 weeks) and their families whose corrected gestational age is between 6-12 months and whose parents' consent has been obtained.
Key inclusion criteria (2 listed)
- Late preterm infants with a corrected age of 6-12 months,
- Infants with parental consent
Key exclusion criteria (3 listed)
- Infants with chromosomal abnormalities,
- having serious congenital problems,
- whose parents are unwilling to work,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief 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 | Behavioural | Late preterm |
| Test 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 | Behavioural | Late preterm |
| Peabody 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. | Behavioural | Late preterm |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Results publication: PubMed 19021850Sadeh 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.
- Results publicationDeGangi GA, Greenspan SI. The development of sensory functions in infants. Physical & Occupational Therapy in Pediatrics. 1989;8(4):21-33.
- Results publication: PubMed 17332185Young 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.
- Results publication: PubMed 16282223Medoff-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.
- Derived from this study: PubMed 41106044Zorlular R, Zorlular A, Elbasan B. Relationship between sleep characteristics, motor development, and sensory processing in late preterm infants. Sleep Med. 2025 Dec;136:106851. doi: 10.1016/j.sleep.2025.106851. Epub 2025 Oct 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia ZORLULAR principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Late Preterm Infant and Motor Development, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peabody Developmental Motor Scales | Second Edition (time frame: 6-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06880588, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.