Clinical trial NCT05322980: Summary of Infants Weighing 500 Grams or Less
Official title: Microcephaly At Birth As a Potential Predictor of Poor Prognosis in Infants Weighing 500 Grams or Less: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Extremely Low Birth Weight
Microcephaly
Keywords: 500 grams or less
prognosis
Lead sponsor: Nagano Children's Hospital
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of neurodevelopmental impairment
timeFrame: 3 years of age
Secondary outcomes:
measure: Survival rate
timeFrame: At discharge from neonatal intensive care unit, an average at 40 weeks' postmenstrual age.
measure: Rate of severe bronchopulmonary dysplasia
timeFrame: At 36 weeks' postmenstrual age
measure: Rate of need for surgery for patent ductus arteriosus
timeFrame: In neonatal intensive care unit, an average of up to 4 weeks of life
measure: Rate of severe intraventricular hemorrhage
timeFrame: In neonatal intensive care unit, an average of up to 2 weeks of life
measure: Rate of periventricular leukomalacia
timeFrame: In neonatal intensive care unit, an average of up to 40 weeks' postmenstrual age
measure: Rate of necrotizing enterocolitis
timeFrame: In neonatal intensive care unit, an average of up to 2 weeks of life
measure: Rate of sepsis
timeFrame: In neonatal intensive care unit, an average of up to 4 weeks of life
measure: Rate of need for treatment for retinopathy of prematurity
timeFrame: In neonatal intensive care unit, an average of up to 40 weeks' postmenstrual age
measure: Weight
timeFrame: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)
measure: Length
timeFrame: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)
measure: Head circumference
timeFrame: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)
measure: Postmenstrual age
timeFrame: At discharge, an average at 40 weeks' postmenstrual age
measure: Need for home oxygen therapy
timeFrame: At discharge, an average at 40 weeks' postmenstrual age
measure: Tracheostomy
timeFrame: In neonatal intensive care unit, an average at 40 weeks' postmenstrual age
measure: Length of hospital stay
timeFrame: In neonatal intensive care unit, an average at 40 weeks' postmenstrual age
measure: Survival rate
timeFrame: At 3 years of age
measure: Modified developmental quotient
timeFrame: At 3 years of age
measure: Rate of cerebral palsy
timeFrame: At 3 years of age
measure: Rate of visual impairment
timeFrame: At 3 years of age
measure: Rate of hearing impairment
timeFrame: At 3 years of age
measure: Rate of those who need home oxygen therapy
timeFrame: At 3 years of age
measure: Rate of those who need tracheostomy
timeFrame: At 3 years of age
measure: Rate of those who need tube feeding or gastrostomy
timeFrame: At 3 years of age
measure: Rate of those who need rehospitalization
timeFrame: After 18 months of corrected age unit until 3 years of age
measure: Weight
timeFrame: At 3 years of age
measure: Height
timeFrame: At 3 years of age
measure: Head circumference
timeFrame: At 3 years of age
Other outcomes:
Locations:
city: Azumino
country: Japan
facility: Nagano Children's Hospital
state: Nagano
Study officials:
affiliation: Nagano Children's Hospital
name: Ryo Itoshima, MD
role: PRINCIPAL_INVESTIGATOR
References: