Hyperbilirubinemia in Full-term Neonates

Phase 4

Recruiting

• Conditions: Hyperbilirubinemia, Neonatal
• Interventions: Other: Sunbathing; Other: Sunbathing and the Oral bifidobacterium triple live powder; Other: Conventional treatment; Drug: Oral bifidobacterium triple live powder

• Registration Number: NCT06238349
• Lead Sponsor: Zhuhai Center for Maternal and Child Health Care

Brief Summary

To evaluate the efficacy and safety of sunbathing and Bifidobacterium alone or in combination for full-term neonates with hyperbilirubinemia. The investigators hypothesize that the combination therapy of sunbathing plus Bifidobacterium is safe and effective for prevention and management of hyperbilirubinemia in full-term neonates. The investigators therefore design this prospective, randomized, controlled study to assess the preventive effects of sunbathing combined with Bifidobacterium supplementation on hyperbilirubinemia in full-term neonates. These observations may provide scientific evidence for the use of sunbathing and Bifidobacterium supplementation in the management of hyperbilirubinemia in full-term neonates.

Detailed Description

To evaluate the efficacy and safety of sunbathing and Bifidobacterium alone or in combination for full-term neonates with hyperbilirubinemia. The investigators hypothesize that the combination therapy of sunbathing plus Bifidobacterium is safe and effective for prevention and management of hyperbilirubinemia in full-term neonates. The investigators therefore design this prospective, randomized, controlled study to assess the preventive effects of sunbathing combined with Bifidobacterium supplementation on hyperbilirubinemia in full-term neonates. A total of 200 neonates treating in Zhuhai Center for Maternal and Child Health Care from Jan. 2024 to Jun. 2024 will be randomized assigned to either trial groups (receiving sunbathing and Bifidobacterium either alone or in combination) or control group receiving traditional therapy. The primary outcome is the incidence of the hyperbilirubinemia and the secondary outcomes include the hospitalization rate, the hospital stays due to hyperbilirubinemia, and the bilirubin levels. Statistical analyses will be performed using ANOVA or chi-square tests, and further pairwise comparisons will be performed using the Bonferroni correction.

Study Timeline

• Study Start: 2024-01-23
• Study First Submitted: 2024-01-23
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sunbathing group	Sunbathing	The sunbathing group will receive all interventions prescribed for the control group and assign to sunbathing (placement in a bed next to a sunny window) after birth for one week according to the following plan: Every morning and afternoon neonates will sunbath for 0.5 to 1 hour to avoid excess sun exposure. Healthcare workers will guide and assist families in their preparations. The caregiver will place a black eye patch on the infants to protect the retina, and a cloth will be wrapped around the hands and feet to prevent scratching, but care will be taken that the wrap is not too tight to avoid circulation disorders. Baby boys will have their genitals covered to protect them from sun damage. After feeding, the newborn will be placed on a sunny platform with fully exposed skin and frequent position changes, while the glass of the window prevent injury from UV light exposure.
Combination group	Sunbathing and the Oral bifidobacterium triple live powder	The combination group will receive all interventions of both the group sunbathing and the Bifidobacterium group as well as all interventions prescribed for the control group.
Control group	Conventional treatment	Conventional treatment: Neonates will be placed in an incubator (Ningbo David Medical Device Co., LTD, XHZ model) at 30℃ and relative humidity at 55%. Throughout the study, exclusive breastfeeding and professional care will be provided for the newborns. Newborns requiring phototherapy receive it in the following manner: Phototherapy eye masks (Foshan Forman Medical Technology Co., LTD., Yuesun Mechanical Equipment No. 20160015) and phototherapy diapers (Foshan Baojusheng Medical Equipment Co., LTD., GB/T33280) will be used to cover the eyes and perineum, respectively. Phototherapy was provided via LED blue light continuous irradiation with a wavelength of 425-475nm. All treated neonates will receive continuous phototherapy for 12 hours, then allowe to rest for 6-8 hours, then receive another 12 hours of continuous phototherapy. The decision to continue with further treatment depends on changes in the neonate's jaundice.
Bifidobacterium group	Oral bifidobacterium triple live powder	The newborns in the Bifidobacterium group will receive all interventions prescribed for the control group, and also be assigned to orally be given Bifidobacterium triple viable powder (Shanghai Xinyi Pharmaceutical Company, Peifeikang powder, 0.5 g/dose, 3 times/day. Bifidobacterium triple viable powder contains live bacteria of long Bifidobacterium at no less than 1.0 × 107 CFU/g, stored at 2.8℃ away from light) beginning within 24 hours after birth and continuing for 1 week. No sunbathing will be prescribed.

Primary Outcome Measures

Name	Time	Method
Numbers of participants with hyperbilirubinemia	From 1 to 7 days after birth	Comparisons will be made of the numbers of neonates with hyperbilirubinemia between groups (Sunbathing group vs. Control group, Bifidobacterium group vs. Control group, Combination group vs. Control group, Combination group vs. sunbathing group, Combination group vs. Bifidobacterium group, and Bifidobacterium vs. sunbathing group).

Secondary Outcome Measures

Name	Time	Method
Rate of hospitalization	From 1 to 7 days after birth	Comparisons will be made in hospitalization rate in the first week of life between groups (sunbathing group vs. Control group, Bifidobacterium group vs. Control group, Combination group vs. Control group, Combination group vs. sunbathing group, Combination group vs. Bifidobacterium group, and Bifidobacterium vs. sunbathing group).
Hospital stays due to hyperbilirubinemia	From 1 to 7 days after birth	Comparisons will be made in hospital stays due to hyperbilirubinemia in the first week of life between groups (sunbathing group vs. Control group, Bifidobacterium group vs. Control group, Combination group vs. Control group, Combination group vs. sunbathing group, Combination group vs. Bifidobacterium group, and Bifidobacterium vs. sunbathing group).
Participants's bilirubin levels	From 1 to 7 days after birth	Comparisons will be made in bilirubin levels in the first week of life between groups (sunbathing group vs. Control group, Bifidobacterium group vs. Control group, Combination group vs. Control group, Combination group vs. sunbathing group, Combination group vs. Bifidobacterium group, and Bifidobacterium vs. sunbathing group).

Trial Locations

Locations (1)

Zhuhai Center for Maternal and Child Health Care; 🇨🇳 Zhuhai, Guangdong, China