Modified Diagnosis and Treatment of Neonatal Hemolysis Incorporated With ETCOc Measurement in Severe Neonatal Hyperbilirubinemia Management
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- neural damage confirmed by professional assessments such as Bayley Scales
Study Overview
Brief Summary
The goal of this clinical trial is to learn if modified diagnosis and treatment (MDT) of neonatal hemolysis (a common cause to newborn jaundice) incorporated with ETCOc measurement (a non-invasive measurement of exhaled gas) works to prevent brain damage in newborns with severe hyperbilirubinemia (sNH). It will also learn about the. occurrence of cranial MRI in the study participants. The main questions it aims to answer are:
- Does MDT lower the possibilities participants have brain damage before the age of one?
- How many times of abnormalities in cranial MRI is detected before the age of one? Researchers will compare MDT to a control (a current management) to see if MDT works to prevent brain damage in newborns with sHN.
Participants will:
- Take MDT or a control method in the management of sNH
- Assess if there's brain damage before discharge and at the year of one
- Record how many times of abnormalities in cranial MRI is detected before the age of one
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 4 Hours to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria:
- •Infants with gestational age of 35(+0) to 41(+6) weeks and birth weight ≥ 2500 grams
- •Infants with severe neonatal hyperbilirubinemia, including those whose serum total
- •bilirubin (TSB) levels reach above 20 mg/dL or whose TSB levels at any time reach within 2 mg/dL of the exchange transfusion threshold (i.e., TSB > (threshold - 2) mg/dL).
Exclusion Criteria
- •Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.
Arms & Interventions
study
modified diagnosis and treatment (MDT) for neonatal hemolysis
Intervention: MDT (Combination Product)
control
Control (current) method for sNH (severe neonatal hemolysis) with the description as follow：
- Diagnosis of neonatal hemolysis： The neonatal subjects with symptom of hyperbilirubinemia are diagnosed as hemolysis if they have positive Direct Antiglobulin Test (DAT) or positive release test result.
- Exchange transfusion (ET) therapy for sNH： The neonatal subjects with symptom of hyperbilirubinemia are treated with ET therapy if their Total serum bilirubin (TSB) reaches or exceeds the current exchange transfusion threshold;
Intervention: control (current management) (Other)
Outcomes
Primary Outcomes
neural damage confirmed by professional assessments such as Bayley Scales
Time Frame: at the age of 12 months
Neurological impairment, including any of the following: diagnosis of cerebral palsy, diagnostic hearing tests indicating hearing impairment, or a score lower than 85 on the Bayley Scales Neurobehavioral Assessment. Bayley Scales means Bayley Scales of Infant and Toddler Development and it can assess the neural development of infants including Cognitive, Language (Receptive/Expressive), Motor (Fine/Gross), Social-Emotional, and Adaptive Behavior. Standard scores for each domain range from 40 to 160 (mean = 100; SD = 15). Higher scores indicate better developmental outcomes, while lower scores suggest potential delays. For example, a cognitive score of 115 reflects performance above the average range, whereas a score of 85 falls below the average range.
Secondary Outcomes
No secondary outcomes reported