Longitudinal research in changes in Japanese infant cranial deformation and exploration the relationship between cranial deformation in infants and sleep-related factors

Trends in the frequency of cranial deformities in infants by the longitudinal research and exploration the relationship between cranial deformation in infants and sleep-related factors - Trends in the frequency of cranial deformities in infants by the longitudinal research and exploration the factors

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052343

Enrollment

250

Registered

2023-09-28

Start date

2023-05-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cranial deformation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The target population for the cranial measurements is 4 months, 1.5- and 3-year-old children undergoing infant health examinations. The caregivers (mainly mothers) of thechildren who can understand Japanese will be asked to answer the questionnaire.

Exclusion criteria

Exclusion criteria: Any disease or complication related to the cranium that is being seen.

Design outcomes

Primary

Measure	Time frame
cranial deformation rate(4 months, 1.5 years, and 3 years of age): Index of cranial asymmetry (CA), cranial vault asymmetry index(CVAI) and so on, by 3D scanner.	—

Secondary

Measure	Time frame
1.Physical measurements and conditions at the time of delivery of the child: The conditions at the time of delivery (number of weeks of gestation, mode of delivery, sex,birth weight, special notes at the time of delivery, etc.) will be determined from the Maternal and Child Health Handbook. In addition, physical measurements at the time ofhealth examination and risk factors for orientation (birth order, nutritional method, cervical dystocia, hip opening/closing restriction, etc.) will be identifi ed. 2.Sleep-related information: The Japanese version of the Brief Infant Sleep Questionnaire-Revised (BISQ-R) will be used to ascertain infants' total sleep time, nighttime anddaytime sleep time, number of awakenings and awakening times, and caregiver responses when they fall asleep. The BISQ-R is used to ascertain the infant's total sleeptime, nighttime and daytime sleep time, number of awakenings, and the caregiver's response to sleep onset. Questionnaire with 7 items related to family background and 33items related to the child's sleep status	—

Measure

Time frame

1.Physical measurements and conditions at the time of delivery of the child: The conditions at the time of delivery (number of weeks of gestation, mode of delivery, sex,birth weight, special notes at the time of delivery, etc.) will be determined from the Maternal and Child Health Handbook. In addition, physical measurements at the time ofhealth examination and risk factors for orientation (birth order, nutritional method, cervical dystocia, hip opening/closing restriction, etc.) will be identifi ed. 2.Sleep-related information: The Japanese version of the Brief Infant Sleep Questionnaire-Revised (BISQ-R) will be used to ascertain infants' total sleep time, nighttime anddaytime sleep time, number of awakenings and awakening times, and caregiver responses when they fall asleep. The BISQ-R is used to ascertain the infant's total sleeptime, nighttime and daytime sleep time, number of awakenings, and the caregiver's response to sleep onset. Questionnaire with 7 items related to family background and 33items related to the child's sleep status

—

Countries

Japan

Contacts

Public ContactChiemi Kiyota

Nagasaki University Institute of Biomedical Sciences

chi0104@nagasaki-u.ac.jp095-819-7198

Outcome results