Hyperbilirubinemia, Neonatal Clinical Trial
Official title:
Efficacy and Safety of Sunbathing Plus Bifidobacterium for Hyperbilirubinemia in Full-term Neonates: a Prospective Randomized Controlled Study
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04868019 -
Role of Fenofibrate in Indirect Neonatal Hyperbilirubinemia: a Randomized Control Trial
|
N/A | |
Completed |
NCT00114543 -
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
|
Phase 3 | |
Completed |
NCT02000830 -
Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
|
||
Completed |
NCT01887327 -
Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
|
Phase 2 | |
Completed |
NCT05356273 -
The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy
|
N/A | |
Suspended |
NCT03741803 -
Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
|
N/A | |
Recruiting |
NCT03876678 -
The Efficacy of Oral Probiotics on Neonatal Hyperbilirubinemia
|
N/A | |
Not yet recruiting |
NCT05365984 -
Intelligent Follow-up of Neonatal Jaundice Based on Early Indicators and Internet Communications
|
N/A | |
Recruiting |
NCT04251286 -
Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network
|
||
Completed |
NCT03723005 -
A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
|
||
Recruiting |
NCT06087874 -
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice
|
Phase 2 | |
Completed |
NCT03624335 -
Influence of Umbilical Cord Clamping Time in the Newborn
|
N/A | |
Recruiting |
NCT06324799 -
The Effect of Position Change Frequency on Hyperbilirubinemia
|
N/A | |
Recruiting |
NCT06209489 -
White Cover and Massage Impact on Bilirubin Levels and Phototherapy Duration in Newborns
|
N/A | |
Completed |
NCT03824990 -
Multi-center Clinical Study on Neonatal Hyperbilirubinemia
|
N/A | |
Withdrawn |
NCT01330667 -
Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
|
N/A | |
Completed |
NCT01169740 -
Transcutaneous Measurement of Jaundice in the Newborn
|
N/A | |
Completed |
NCT03007563 -
Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
|
N/A | |
Completed |
NCT01763632 -
Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants
|
N/A | |
Completed |
NCT01762189 -
The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants
|
N/A |