Hyperbilirubinemia in Full-term Neonates

Launched by ZHUHAI CENTER FOR MATERNAL AND CHILD HEALTH CARE · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective and safe sunbathing and a type of probiotic called Bifidobacterium are for treating jaundice in full-term newborns. Jaundice, which happens when there is too much bilirubin in the blood, can cause yellowing of the skin and eyes in babies. Researchers believe that combining sunbathing with Bifidobacterium might help manage jaundice better than using either method alone. The trial aims to gather evidence to support this treatment approach.

To be eligible for the study, babies must be born between 37 and 42 weeks, weigh between 2,500 and 4,000 grams, and should be less than 24 hours old. They should also be healthy, with stable vital signs and normal liver and kidney function. Mothers should have had a healthy pregnancy and not used antibiotics recently. Participants can expect to receive either sunbathing, Bifidobacterium, or a combination of both as part of the study. The researchers will monitor the babies closely to see how well these treatments work together. Overall, this trial could provide important insights into safer and more effective ways to treat jaundice in newborns.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Term infants with 37 weeks ≤ gestational age \< 42 weeks and 2500g ≤ birth weight \< 4000g
• • Age ≤24 hours
• • Stable basic vital signs
• • Liver and kidney function normal
• • No prior use of antibiotics or ecological agents before specimen collection
• • Healthy mothers during pregnancy, with no history of antibiotics or microecological agents before, during, or after childbirth
• • Exclusively breastfed
• • Informed consent provided voluntarily.
• Exclusion Criteria:
• • Gestational age \<37 weeks or ≥42 weeks
• • Complications present with pneumonia, septicemia, or other illness
• • Severe immunodeficiency disease present
• • Inherited metabolic diseases identified
• • Congenital biliary malformations or other organ malformations
• • Drug allergies
• • History of asphyxiation
• • Before enteral feeding, constipation, abdominal distension, diarrhea, vomiting or other gastrointestinal symptoms had appeared
• • Enteral feeding was not performed
• • Antibiotics or other microecological agents were used
• • Isoimmune hemolysis, extravascular hemolysis, polycythemia, erythrocyte enzyme deficiency, erythrocyte morphological abnormality, hemoglobinopathy, etc.
• • Hyperbilirubinemia were diagnosed within 24 hours of birth
• • Situations that may warrant exclusion as determined by the researcher, such as a guardian with mental illness or frequent changes in living or working environments, which might result in loss of follow-up