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Efficacy of home phototherapy versus inpatient phototherapy for neonatal hyperbilirubinemia: a randomised controlled trial

Efficacy of home phototherapy versus inpatient phototherapy for neonatal hyperbilirubinemia: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110128
Enrollment
Unknown
Registered
2025-09-30
Start date
2025-10-08
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Neonatal hyperbilirubinemia

Interventions

Home Phototherapy Group:Newborns with hyperbilirubinemia receive phototherapy at home, and team members provide instructions on how to use it, precautions, and nursing.
Inpatient Phototherapy Group:Neonates with hyperbilirubinemia are hospitalized in hospitals to receive standard phototherapy.

Sponsors

Longgang District Maternity & Child Healthcare Hospital of Shenzhen City (Longgang Maternity and Child Institute of Shantou University Medical College)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Term neonates discharged from the maternity ward (gestational age at birth >=38 weeks); 2. Age >=2 days; 3. Good clinical condition and adequate feeding, weight >2500g, weight loss <10% of birth weight; 4. No previous phototherapy; 5. Neonates with lower bilirubin level below 2mg/dL of phototherapy threshold; 6. Neonates whose bilirubin ceiling did not exceed the phototherapy threshold of 1mg/dL; 7. There were no known risk factors for high biliary neurotoxicity, including (a) jaundice observed within the first 24 hours of life, (b) blood group incompatibility or other hemolytic disease, (c) gestational age <=38 weeks, (d) parental history of jaundice in the child, (e) difficulties in nursing exclusive breastfeeding, and (f) hematoma or visible bruising; 8. There are no neurotoxic symptoms, such as neurological signs, acidosis, hypoxia, body temperature instability, or infection; 9. Newborns must live within the intervention area and be monitored on daily return visits; 10. The parents of the newborn have no cognitive and language communication disorders, and can use smart phones without barrier. 11. Parents agreed and voluntarily participated in the study protocol by signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Neonatal cholestasis or conjugated bilirubin elevation; 2. Early discharge from the maternity ward (vaginal delivery <48 hours, cesarean section <72 hours); 3. Congenital metabolic diseases, congenital malformations, congenital genetic diseases; 4. History of neonatal asphyxia; 5. Parents who could not speak Mandarin or could not receive home phototherapy according to the medical evaluation;

Design outcomes

Primary

MeasureTime frame
Duration of phototherapy;Total treatment time;Decrease in bilirubin level;Hospital readmission;

Secondary

MeasureTime frame
Self-Rating Anxiety Scale;Self-Rating Depression Scale;Exchange transfusion;

Countries

China

Contacts

Public ContactLi Rui

Longgang District Maternity & Child Healthcare Hospital of Shenzhen City (Longgang Maternity and Child Institute of Shantou University Medical College)

13045425766@163.com+86 755 2893 3003

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026