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Completed

NCT Number: NCT05322980

Summary of Infants Weighing 500 Grams or Less

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.

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Key information

Conditions

Infant, Extremely Low Birth Weight Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Malformations of Cortical Development Malformations of Cortical Development, Group I Microcephaly Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Nervous System Malformations

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagano Children's Hospital

Azumino, Nagano, 399-8288, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microcephaly

Diagnostic Test

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

Primary outcomes

  1. Rate of neurodevelopmental impairment

    Time frame: 3 years of age

    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.

Secondary outcomes

  1. Survival rate

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

    Survival rate is the proportion of those have survived.

  2. Rate of severe bronchopulmonary dysplasia

    Time frame: At 36 weeks' postmenstrual age

    The definition of bronchopulmonary dysplasia proposed by the National Institute of Child Health and Human Development is used to classify the severity of bronchopulmonary dysplasia. Those who need ≥ 30% of oxygen or any mechanical respiratory support at 36 weeks of gestation are classified as having severe bronchopulmonary dysplasia.

  3. Rate of need for surgery for patent ductus arteriosus

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

    Patent ductus arteriosus is diagnosed by neonatologists using echocardiography and clinical signs.

  4. Rate of severe intraventricular hemorrhage

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

    Intraventricular hemorrhage is diagnosed by neonatologists using head ultrasound. Severe IVH was defined as grade III or IV by the classification of Papile.

  5. Rate of periventricular leukomalacia

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

    Periventricular leukomalacia is diagnosed using head ultrasound or magnetic resonance imaging, typically cysts formation in the periventricular white matter.

  6. Rate of necrotizing enterocolitis

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

    The diagnosis with necrotizing enterocolitis.

  7. Rate of sepsis

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

    Sepsis is defined as septicemia or bacteremia with a positive culture result of the blood and/or cerebrospinal fluid.

  8. Rate of need for treatment for retinopathy of prematurity

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

    The diagnosis of retinopathy of prematurity and the decision on the need for treatment were made by ophthalmologic examination.

  9. Weight

    Time frame: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)

    Physical measurement.

  10. Length

    Time frame: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)

    Physical measurement.

  11. Head circumference

    Time frame: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)

    Physical measurement.

  12. Postmenstrual age

    Time frame: At discharge, an average at 40 weeks' postmenstrual age

    Postmenstrual age is calculated based on their gestational age and date at birth.

  13. Need for home oxygen therapy

    Time frame: At discharge, an average at 40 weeks' postmenstrual age

    Need for home oxygen therapy.

  14. Tracheostomy

    Time frame: In neonatal intensive care unit, an average at 40 weeks' postmenstrual age

    Need for tracheostomy.

  15. Length of hospital stay

    Time frame: In neonatal intensive care unit, an average at 40 weeks' postmenstrual age

    The initial hospitalization.

  16. Survival rate

    Time frame: At 3 years of age

    Survival rate is the proportion of those have survived.

  17. Modified developmental quotient

    Time frame: At 3 years of age

    Modified developmental quotient is calculated by dividing developmental age (measured by the Kyoto Scale of Psychological Development) by the corrected age.

  18. Rate of cerebral palsy

    Time frame: At 3 years of age

    Cerebral palsy is defined as (1) a non-progressive disorder of the central nervous system appearing in 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.

  19. Rate of visual impairment

    Time frame: At 3 years of age

    Visual impairment is defined as unilateral or bilateral blindness, or any other condition requiring corrective lenses, which were diagnosed or determined by ophthalmologists.

  20. Rate of hearing impairment

    Time frame: At 3 years of age

    Hearing impairment is 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.

  21. Rate of those who need home oxygen therapy

    Time frame: At 3 years of age

    Need for home oxygen therapy.

  22. Rate of those who need tracheostomy

    Time frame: At 3 years of age

    Need for tracheostomy.

  23. Rate of those who need tube feeding or gastrostomy

    Time frame: At 3 years of age

    Need for tube feeding or gastrostomy.

  24. Rate of those who need rehospitalization

    Time frame: After 18 months of corrected age unit until 3 years of age

    Need for rehospitalization.

  25. Weight

    Time frame: At 3 years of age

    Physical measurement.

  26. Height

    Time frame: At 3 years of age

    Physical measurement.

  27. Head circumference

    Time frame: At 3 years of age

    Physical measurement.

Sponsors and collaborators

Lead sponsor

Nagano Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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