NCT05322980

Summary of Infants Weighing 500 Grams or Less

Microcephaly At Birth As a Potential Predictor of Poor Prognosis in Infants Weighing 500 Grams or Less: a Retrospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Nagano Children's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a retrospective single-center cohort study. The comparison in short- and long-term outcomes will be made between those with and without primary microcephaly in infants weighing ≤ 500 g.

Detailed description

This is a retrospective single-center cohort study. The study setting is a level IV neonatal intensive care unit (NICU) at Nagano Children's Hospital in Nagano, Japan. We will retrospectively collect the data of those who were admitted to Nagano Children's Hospital NICU between January 1, 2015, and December 31, 2019. Eligible infants will be identified using our neonatal database and clinical records. The extracted data includes maternal background information and clinical course, infant's status at birth, the clinical course in NICU, and the follow-up data at 6 and 18 months of corrected age. Among the eligible infants, those with a z score of birth head circumference \< -2 will be classified into the Microcephaly group and others into the Control group. The z score is calculated using the Japanese growth standard.

Conditions

• Infant, Extremely Low Birth Weight
• Microcephaly

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Microcephaly	Those with a z score of birth head circumference \< -2 (primary microcephaly) are classified into the Microcephaly group.

Timeline

• Start date: 2022-04-05
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-04-12
• Last updated: 2024-11-20

Locations

1 site across 1 country: Japan