Sleep Characteristics in Late Premature Infants

NCT06880588 | Completed

• 1 other identifier: late premature and sleep
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Late Preterm Infant; Motor Development; Sleep

Keywords

Sleep; late preterm; motor development; sensory processing skill

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6-12 months

Study Arms (1)

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.

Behavioral: Brief Infant Sleep Questionnaire; Behavioral: Test of Sensory Function in Infants; Behavioral: Peabody Motor Development Scale-2

Interventions

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

Late preterm

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

Late preterm

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.

Late preterm

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 19021850 BACKGROUND

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

  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.

  PMID: 17332185 BACKGROUND

• 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.

  PMID: 16282223 BACKGROUND

• Zorlular 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.

  PMID: 41106044 DERIVED

Study Officials

• Rabia ZORLULAR

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 17, 2025
• Study Start: March 19, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)