Summary of Infants Weighing 500 Grams or Less
- Conditions
- Infant, Extremely Low Birth WeightMicrocephaly
- Interventions
- Diagnostic Test: Microcephaly
- Registration Number
- NCT05322980
- Lead Sponsor
- Nagano Children's Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- Live-born infants weighing ≤ 500 g at birth
- Infants whose clinical course is available in the electronic medical record
- Stillbirths
- Infants who received only palliative care at birth
- Outborn infants
- Infants whose assessment at 3 years of age not completed at data analysis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Microcephaly Microcephaly Infants with primary microcephaly.
- Primary Outcome Measures
Name Time Method Rate of neurodevelopmental impairment 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 Outcome Measures
Name Time Method Height At 3 years of age Physical measurement.
Rate of need for surgery for patent ductus arteriosus 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.
Modified developmental quotient 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.
Rate of severe bronchopulmonary dysplasia 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.
Rate of need for treatment for retinopathy of prematurity 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.
Weight At 3 years of age Physical measurement.
Rate of hearing impairment 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.
Rate of those who need rehospitalization After 18 months of corrected age unit until 3 years of age Need for rehospitalization.
Postmenstrual age At discharge, an average at 40 weeks' postmenstrual age Postmenstrual age is calculated based on their gestational age and date at birth.
Length of hospital stay In neonatal intensive care unit, an average at 40 weeks' postmenstrual age The initial hospitalization.
Rate of those who need tracheostomy At 3 years of age Need for tracheostomy.
Rate of those who need tube feeding or gastrostomy At 3 years of age Need for tube feeding or gastrostomy.
Rate of cerebral palsy 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.
Rate of periventricular leukomalacia 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.
Rate of visual impairment 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.
Rate of those who need home oxygen therapy At 3 years of age Need for home oxygen therapy.
Survival rate At 3 years of age Survival rate is the proportion of those have survived.
Rate of severe intraventricular hemorrhage 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.
Rate of necrotizing enterocolitis In neonatal intensive care unit, an average of up to 2 weeks of life The diagnosis with necrotizing enterocolitis.
Need for home oxygen therapy At discharge, an average at 40 weeks' postmenstrual age Need for home oxygen therapy.
Tracheostomy In neonatal intensive care unit, an average at 40 weeks' postmenstrual age Need for tracheostomy.
Rate of sepsis 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.
Length At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age) Physical measurement.
Head circumference At 3 years of age Physical measurement.
Trial Locations
- Locations (1)
Nagano Children's Hospital
🇯🇵Azumino, Nagano, Japan