Evaluating sunbathing and Bifidobacterium for treating jaundice in newborns
Efficacy and Safety of Sunbathing Plus Bifidobacterium for Hyperbilirubinemia in Full-term Neonates: a Prospective Randomized Controlled Study
This study is testing whether sunbathing and a type of good bacteria can help treat jaundice in newborns better than standard treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | N/A to 1 Day |
| Sex | All |
| Sponsor | Zhuhai Center for Maternal and Child Health Care Academic / other |
| Locations | 1 site (Zhuhai, Guangdong) |
| Trial ID | NCT06238349 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness and safety of sunbathing and Bifidobacterium supplementation, both individually and in combination, for the prevention and management of hyperbilirubinemia in full-term neonates. Conducted at the Zhuhai Center for Maternal and Child Health Care, the study will involve 200 neonates who will be randomly assigned to receive either the interventions or traditional therapy. The primary outcome will focus on the incidence of hyperbilirubinemia, while secondary outcomes will include hospitalization rates and bilirubin levels. Statistical analyses will be performed to evaluate the results.
Who should consider this trial
Good fit: Ideal candidates for this study are full-term neonates aged 24 hours or younger, with stable vital signs and normal liver and kidney function.
Not a fit: Patients who are preterm, have severe immunodeficiency, or other significant health complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safe and effective method for preventing and managing jaundice in full-term neonates.
How similar studies have performed: While the combination of sunbathing and Bifidobacterium is a novel approach, similar studies have shown positive outcomes with individual therapies for hyperbilirubinemia.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zhuhai, Guangdong
- Zhuhai Center for Maternal and Child Health Care — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Gaohong Wu, M.M.
- Email: 1217555215@qq.com
- Phone: +8617841565295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.