Hyperbilirubinemia in Full-term Neonates

NCT06238349 | Recruiting Phase 4 DMC

• 2 other identifiers: GWuNKRDRC/2022YFC270480
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbilirubinemia, Neonatal

Keywords

Sunbathing; Bifidobacterium; Prevention; Full-term neonates; Hyperbilirubinemia; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Numbers of participants with hyperbilirubinemia

  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).

  From 1 to 7 days after birth

Secondary Outcomes (3)

• Rate of hospitalization

  From 1 to 7 days after birth

• Hospital stays due to hyperbilirubinemia

  From 1 to 7 days after birth

• Participants's bilirubin levels

  From 1 to 7 days after birth

Other Outcomes (9)

• Numbers of participants with adverse event

  From 1 to 7 days after birth

• Numbers of participants with single or multiple births

  From 1 to 7 days after birth

• Numbers of participants with intrauterine distress

  From 1 to 7 days after birth

Study Arms (4)

Control group

OTHER

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.

Other: Conventional treatment

Sunbathing group

EXPERIMENTAL

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.

Other: Sunbathing

Bifidobacterium group

EXPERIMENTAL

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.

Drug: Oral bifidobacterium triple live powder

Combination group

EXPERIMENTAL

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.

Other: Sunbathing and the Oral bifidobacterium triple live powder

Interventions

Oral bifidobacterium triple live powder DRUG

The newborns in the Bifidobacterium group will receive all interventions prescribed for the control group, and also were 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.

Also known as: Conventional treatment

Bifidobacterium group

Sunbathing OTHER

The sunbathing group will receive all interventions prescribed for the control group and be assigned 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 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.

Sunbathing group

Sunbathing and the Oral bifidobacterium triple live powder OTHER

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.

Combination group

Conventional treatment OTHER

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.

Control group

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhuhai Center for Maternal and Child Health Care: lead
• Children's Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Zhuhai Center for Maternal and Child Health Care

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuan Shi, M.D.

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Gaohong Wu, M.M.

CONTACT

+8617841565295; 1217555215@qq.com

Qingyang Ji, M.M.

CONTACT

+8617549615778; 2819375906@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 2, 2024
• Study Start: January 23, 2024
• Primary Completion: June 21, 2024
• Study Completion: June 28, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)