Infant, Extremely Low Birth WeightNCT05322980
Summary of Infants Weighing 500 Grams or Less
An observational study of Infant, Extremely Low Birth Weight and Microcephaly, run by Nagano Children's Hospital at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Extremely Low Birth Weight, Microcephaly
- What is being tested?
- Microcephaly
- How many people
- 22 participants
- Where
- 1 siteJapan
- Study dates
- 5 Apr 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Those who were admitted to Nagano Children's Hospital NICU between January 1, 2010, and December 31, 2019.
Who may be able to join
- Live-born infants weighing ≤ 500 g at birth
- Infants whose clinical course is available in the electronic medical record
Who cannot join
- Stillbirths
- Infants who received only palliative care at birth
- Outborn infants
- Infants whose assessment at 3 years of age not completed at data analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microcephaly At Birth As a Potential Predictor of Poor Prognosis in Infants Weighing 500 Grams or Less: a Retrospective Cohort Study
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.
Read the 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.
- Conditions
- Infant, Extremely Low Birth Weight, Microcephaly
- Being tested
- Microcephaly
- Keywords
- 500 grams or less, prognosis
- Medical subject headings
- Microcephaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrocephalyDiagnostic test
Those with a z score of birth head circumference < -2 (primary microcephaly) are classified into the Microcephaly group.
| Study group | Role | What they receive |
|---|---|---|
| Microcephaly | Infants with primary microcephaly. Receives: Diagnostic Test: Microcephaly | |
| Control | Infants without primary microcephaly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years of age
Secondary outcomes (27)
Survival rate
Survival rate is the proportion of those have survived.
Measured: At discharge from neonatal intensive care unit, an average at 40 weeks' postmenstrual age.
Rate of severe bronchopulmonary dysplasia
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.
Measured: At 36 weeks' postmenstrual age
Rate of need for surgery for patent ductus arteriosus
Patent ductus arteriosus is diagnosed by neonatologists using echocardiography and clinical signs.
Measured: In neonatal intensive care unit, an average of up to 4 weeks of life
Rate of severe intraventricular hemorrhage
Intraventricular hemorrhage is diagnosed by neonatologists using head ultrasound. Severe IVH was defined as grade III or IV by the classification of Papile.
Measured: In neonatal intensive care unit, an average of up to 2 weeks of life
Rate of periventricular leukomalacia
Periventricular leukomalacia is diagnosed using head ultrasound or magnetic resonance imaging, typically cysts formation in the periventricular white matter.
Measured: In neonatal intensive care unit, an average of up to 40 weeks' postmenstrual age
Rate of necrotizing enterocolitis
The diagnosis with necrotizing enterocolitis.
Measured: In neonatal intensive care unit, an average of up to 2 weeks of life
Rate of sepsis
Sepsis is defined as septicemia or bacteremia with a positive culture result of the blood and/or cerebrospinal fluid.
Measured: In neonatal intensive care unit, an average of up to 4 weeks of life
Rate of need for treatment for retinopathy of prematurity
The diagnosis of retinopathy of prematurity and the decision on the need for treatment were made by ophthalmologic examination.
Measured: In neonatal intensive care unit, an average of up to 40 weeks' postmenstrual age
Weight
Physical measurement.
Measured: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)
Length
Physical measurement.
Measured: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)
Head circumference
Physical measurement.
Measured: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)
Postmenstrual age
Postmenstrual age is calculated based on their gestational age and date at birth.
Measured: At discharge, an average at 40 weeks' postmenstrual age
Need for home oxygen therapy
Need for home oxygen therapy.
Measured: At discharge, an average at 40 weeks' postmenstrual age
Tracheostomy
Need for tracheostomy.
Measured: In neonatal intensive care unit, an average at 40 weeks' postmenstrual age
Length of hospital stay
The initial hospitalization.
Measured: In neonatal intensive care unit, an average at 40 weeks' postmenstrual age
Survival rate
Survival rate is the proportion of those have survived.
Measured: At 3 years of age
Modified developmental quotient
Modified developmental quotient is calculated by dividing developmental age (measured by the Kyoto Scale of Psychological Development) by the corrected age.
Measured: At 3 years of age
Rate of cerebral palsy
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.
Measured: At 3 years of age
Rate of visual impairment
Visual impairment is defined as unilateral or bilateral blindness, or any other condition requiring corrective lenses, which were diagnosed or determined by ophthalmologists.
Measured: At 3 years of age
Rate of hearing impairment
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.
Measured: At 3 years of age
Rate of those who need home oxygen therapy
Need for home oxygen therapy.
Measured: At 3 years of age
Rate of those who need tracheostomy
Need for tracheostomy.
Measured: At 3 years of age
Rate of those who need tube feeding or gastrostomy
Need for tube feeding or gastrostomy.
Measured: At 3 years of age
Rate of those who need rehospitalization
Need for rehospitalization.
Measured: After 18 months of corrected age unit until 3 years of age
Weight
Physical measurement.
Measured: At 3 years of age
Height
Physical measurement.
Measured: At 3 years of age
Head circumference
Physical measurement.
Measured: At 3 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start5 Apr 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Extremely Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagano Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryo Itoshima, Nagano Children's Hospital
- Investigators
- Ryo Itoshima, MD, Principal investigator, Nagano Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322980
- Sponsor's protocol ID
- summary-500g
- Status last verified
- Nov 2024
- First submitted
- 4 Mar 2022
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcephaly At Birth As a Potential Predictor of Poor Prognosis in Infants Weighing 500 Grams or Less: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05322980
- Acronym / sponsor ID
- summary-500g
- Conditions
- Infant, Extremely Low Birth Weight, Microcephaly
- Keywords
- 500 grams or less, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nagano Children's HospitalUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microcephaly | – | Diagnostic Test: MicrocephalyInfants with primary microcephaly. |
| Control | – | –Infants without primary microcephaly. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those who were admitted to Nagano Children's Hospital NICU between January 1, 2010, and December 31, 2019.
Key inclusion criteria (2 listed)
- Live-born infants weighing ≤ 500 g at birth
- Infants whose clinical course is available in the electronic medical record
Key exclusion criteria (4 listed)
- Stillbirths
- Infants who received only palliative care at birth
- Outborn infants
- Infants whose assessment at 3 years of age not completed at data analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrocephalyThose with a z score of birth head circumference < -2 (primary microcephaly) are classified into the Microcephaly group. | Diagnostic test | Microcephaly |
Primary outcome
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.
27 secondary outcomes
Survival rate
Time frame: At discharge from neonatal intensive care unit, an average at 40 weeks' postmenstrual age.
Rate of severe bronchopulmonary dysplasia
Time frame: At 36 weeks' postmenstrual age
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
Rate of severe intraventricular hemorrhage
Time frame: In neonatal intensive care unit, an average of up to 2 weeks of life
Rate of periventricular leukomalacia
Time frame: In neonatal intensive care unit, an average of up to 40 weeks' postmenstrual age
Rate of necrotizing enterocolitis
Time frame: In neonatal intensive care unit, an average of up to 2 weeks of life
Rate of sepsis
Time frame: In neonatal intensive care unit, an average of up to 4 weeks of life
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
Weight
Time frame: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)
Length
Time frame: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)
Head circumference
Time frame: At 40 weeks' postmenstrual age or at discharge (approximately 40 weeks' postmenstrual age)
Postmenstrual age
Time frame: At discharge, an average at 40 weeks' postmenstrual age
Need for home oxygen therapy
Time frame: At discharge, an average at 40 weeks' postmenstrual age
Tracheostomy
Time frame: In neonatal intensive care unit, an average at 40 weeks' postmenstrual age
Length of hospital stay
Time frame: In neonatal intensive care unit, an average at 40 weeks' postmenstrual age
Survival rate
Time frame: At 3 years of age
Modified developmental quotient
Time frame: At 3 years of age
Rate of cerebral palsy
Time frame: At 3 years of age
Rate of visual impairment
Time frame: At 3 years of age
Rate of hearing impairment
Time frame: At 3 years of age
Rate of those who need home oxygen therapy
Time frame: At 3 years of age
Rate of those who need tracheostomy
Time frame: At 3 years of age
Rate of those who need tube feeding or gastrostomy
Time frame: At 3 years of age
Rate of those who need rehospitalization
Time frame: After 18 months of corrected age unit until 3 years of age
Weight
Time frame: At 3 years of age
Height
Time frame: At 3 years of age
Head circumference
Time frame: At 3 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryo Itoshima, MD principal investigator
Nagano Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Extremely Low Birth Weight and Microcephaly, run by Nagano Children's Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of neurodevelopmental impairment (time frame: 3 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.