Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate and Severe Infants
Study Purpose
Atopic Dermatitis (AD) is a common chronic, recurrent, and inflammatory skin disease in children. The incidence of moderate to severe AD in infants aged 1-12 months in our country is as high as 25.41%, which is related to subsequent allergic diseases and affects Children's emotions and growth. There are limited drugs that can be used for infant AD. The current guidelines recommend early use of functional skin care products to prevent and treat AD by repairing the skin barrier, moisturizing, and anti-inflammatory. Neonatal jaundice is one of the most common neonatal diseases. 20% of children with jaundice need phototherapy. It is a simple and effective method for jaundice. Studies have found that phototherapy can convert Th2 to Th1, leading to an imbalance of pro-inflammatory and anti-inflammatory, which induces allergies. We speculate that it is of great value to take protective measures such as skin moisturizing during phototherapy for jaundice in children at high risk of allergies. This project intends to take the lead in conducting a randomized controlled study on the use of baby moisturizing products during neonatal phototherapy. Through evaluation projects such as skin microecology analysis, serum allergy indicators and AD clinical manifestations, it is verified that the use of functional skin care products in phototherapy of newborns with high allergies can delay and reduce the severity of AD in infants.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 37 Weeks - 42 Weeks |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05178433 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Shanghai First Maternity and Infant Hospital |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Li Jing |
Principal Investigator Affiliation | Shanghai First Maternity and Infant Health Hospital |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Not yet recruiting |
Countries | |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Neonatal Jaundice, Atopic Dermatitis |
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Li Jing
For additional contact information, you can also visit the trial on clinicaltrials.gov.