Summary of Infants Weighing 500 Grams or Less

NCT05322980 | Completed

• 1 other identifier: summary-500g
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant, Extremely Low Birth Weight; Microcephaly

Keywords

500 grams or less; prognosis

Outcome Measures

Primary Outcomes (1)

• Rate of neurodevelopmental impairment

  Having at least one of the following conditions: cognitive impairment, cerebral palsy, visual impairment, or hearing impairment. Cognitive impairment was defined as a modified DQ score of ≤ 70 using the Kyoto Scale of Psychological Development. CP was defined as (1) a non-progressive disorder of the central nervous system appearing in the early years of life and clinically characterized by a persistent but not unchanging impairment of movement and posture and/or (2) the Gross Motor Function Classification System level ≥ II. Visual impairment was defined as unilateral or bilateral blindness, or any other condition requiring corrective lenses, which were diagnosed or determined by ophthalmologists. Hearing impairment was defined as unilateral or bilateral hearing loss that requires a hearing aid. The diagnosis of hearing loss was made by otolaryngologists using auditory steady-state response.

  3 years of age

Secondary Outcomes (27)

• Survival rate

  At discharge from neonatal intensive care unit, an average at 40 weeks' postmenstrual age.

• Rate of severe bronchopulmonary dysplasia

  At 36 weeks' postmenstrual age

• Rate of need for surgery for patent ductus arteriosus

  In neonatal intensive care unit, an average of up to 4 weeks of life

• Rate of severe intraventricular hemorrhage

  In neonatal intensive care unit, an average of up to 2 weeks of life

• Rate of periventricular leukomalacia

  In neonatal intensive care unit, an average of up to 40 weeks' postmenstrual age

Study Arms (2)

Microcephaly

Infants with primary microcephaly.

Diagnostic Test: Microcephaly

Control

Infants without primary microcephaly.

Interventions

Microcephaly DIAGNOSTIC_TEST

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

Microcephaly

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those who were admitted to Nagano Children's Hospital NICU between January 1, 2010, and December 31, 2019.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nagano Children's Hospital: lead

Study Sites (1)

Nagano Children's Hospital

Azumino, Nagano, 399-8288, Japan

Location

MeSH Terms

Conditions

Microcephaly

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ryo Itoshima, MD

  Nagano Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: April 12, 2022
• Study Start: April 5, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)