Summary of Infants Weighing 500 Grams or Less

N

Nagano Children's Hospital

Status

Completed

Conditions

Infant, Extremely Low Birth Weight
Microcephaly

Treatments

Diagnostic Test: Microcephaly

Study type

Observational

Funder types

Other

Identifiers

NCT05322980
summary-500g

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Live-born infants weighing ≤ 500 g at birth
  • Infants whose clinical course is available in the electronic medical record

Exclusion criteria

  • Stillbirths
  • Infants who received only palliative care at birth
  • Outborn infants
  • Infants whose assessment at 3 years of age not completed at data analysis

Trial design

22 participants in 2 patient groups

Microcephaly
Description:
Infants with primary microcephaly.
Treatment:
Diagnostic Test: Microcephaly
Control
Description:
Infants without primary microcephaly.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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