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Clinical study on protective effect of docosahexaenoic acid on neonatal bilirubin injury

Clinical study on protective effect of docosahexaenoic acid on neonatal bilirubin injury

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070250
Enrollment
Unknown
Registered
2023-04-06
Start date
2023-04-15
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal bilirubin brain injury

Interventions

observation group:decosahexaenoic acid

Sponsors

Shandong Provincial Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Newborns aged over 35 weeks who met one of the following conditions were included in the high-risk group: (1) Serum total bilirubin (TSB) and percutaneous bilirubin (TcB) levels at the time of admission were in high-risk areas; (2) Jaundice occurs within 24 h after birth; (3) The mother and infant are incompatible with each other and have positive direct antihuman globulin tests, and there are other hemolytic diseases such as glucose-6-phosphate dehydrogenase deficiency (G6PD); (4) The siblings have received phototherapy; (5) Cranial hematoma or obvious bruise; (6) Poor nursing or excessive reduction of body weight when breastfeeding alone. 2. Premature infants aged from 30 weeks to 34 weeks+6 weeks who met one of the following conditions were included in the high-risk group: (1) Jaundice occurs within 24 h after birth; (2) The mother and infant are incompatible with each other and have a positive direct antihuman globulin test, and there are other hemolytic diseases such as glucose-6-phosphate dehydrogenase deficiency (G6PD); (3) The siblings have received phototherapy; (4) Cranial hematoma or obvious bruise; (5) Poor nursing or excessive reduction of body weight when breastfeeding alone.

Exclusion criteria

Exclusion criteria: 1. Children who were allergic to DHA-related components used in the research; 2. Severe infection combined with dysfunction of liver, kidney and other vital organs; 3. Children with metabolic diseases.

Design outcomes

Primary

MeasureTime frame
serum neuron-specific enolase;transcutaneous measurement;nuclear magnetic resonance;

Secondary

MeasureTime frame
Brainstem evoked potential;

Countries

China

Contacts

Public ContactHao Wei

Shandong Provincial Hospital Affiliated to Shandong First Medical University

haowei12875@163.com+86 159 5318 5518

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026