Infant, Extremely Low Birth Weight, Microcephaly
Conditions
Keywords
500 grams or less, prognosis
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.
Interventions
DIAGNOSTIC_TESTMicrocephaly
Those with a z score of birth head circumference \< -2 (primary microcephaly) are classified into the Microcephaly group.
Sponsors
Nagano Children's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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 necrotizing enterocolitis | In neonatal intensive care unit, an average of up to 2 weeks of life | The diagnosis with necrotizing enterocolitis. |
| 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. |
| 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 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age) | Physical measurement. |
| Length | At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age) | Physical measurement. |
| Head circumference | At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age) | Physical measurement. |
| Postmenstrual age | At discharge, an average at 40 weeks' postmenstrual age | Postmenstrual age is calculated based on their gestational age and date at birth. |
| Survival rate | At discharge from neonatal intensive care unit, an average at 40 weeks' postmenstrual age. | Survival rate is the proportion of those have survived. |
| Tracheostomy | In neonatal intensive care unit, an average at 40 weeks' postmenstrual age | Need for tracheostomy. |
| Length of hospital stay | In neonatal intensive care unit, an average at 40 weeks' postmenstrual age | The initial hospitalization. |
| 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 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 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 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 home oxygen therapy | At 3 years of age | Need for home oxygen therapy. |
| 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 those who need rehospitalization | After 18 months of corrected age unit until 3 years of age | Need for rehospitalization. |
| Height | At 3 years of age | Physical measurement. |
| Need for home oxygen therapy | At discharge, an average at 40 weeks' postmenstrual age | Need for home oxygen therapy. |
Countries
Japan
Outcome results
None listed