Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate and Severe Infants

January 13, 2022 updated by: Shanghai First Maternity and Infant Hospital

Randomized Controlled Study of Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate and Severe Infants

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Atopic Dermatitis (AD) is a common chronic, recurrent, and inflammatory skin disease. The onset before 1 year old accounts for about 50% of all patients. The main manifestations are dry skin, chronic eczema-like dermatitis and severe itching. The incidence of AD in infants worldwide is as high as 30%. In our country, the prevalence of AD among infants aged 1-12 months is 30.48%, of which 23.97% are moderate and 1.44% are severe. Infant AD is mostly related to non-IgE-mediated food allergies. The prevalence rate of food allergy in children with moderate to severe AD under 2 years of age in our country is 49.7% confirmed by food provocation test, which seriously affects the nutritional intake and growth and development of children. Cause psychological and economic burdens on children and their families. At present, AD is considered to be a multifactorial disease, involving genetic susceptibility, immune disorders, microbial flora imbalance, environmental factors, and skin barrier function defects. Different from adults, the immune system of infants and young children is not yet mature. AD, allergic asthma and allergic rhinitis are known as the triad of children's atopic. Among them, AD is the earliest age of onset. It may be the first step in the process of allergic diseases. It is unique The pathogenesis related research is relatively limited, and there are only a handful of drugs approved for infantile AD. Therefore, the prevention of moderate to severe infantile AD should be more important than treatment.

Neonatal jaundice is one of the most common neonatal disorders. The incidence of full-term infants within one week of birth is 60%, and premature infants are as high as 80%. Among them, in order to prevent and treat bilirubin encephalopathy, children with severe neonatal hyper-indirect bilirubinemia need to receive phototherapy. The most commonly used blue light therapy in clinical practice is a simple, effective and relatively safe measure to reduce jaundice. About 20% of children with jaundice receive phototherapy. Bilirubin is an antioxidant that can neutralize free radicals produced in the body after birth. The imbalance of the body's oxidation-antioxidation mechanism may cause allergic diseases. Studies have focused on the occurrence and development of neonatal jaundice and allergic diseases. At the same time, blue light therapy is suitable for moderate to severe neonatal hyperbilirubinemia, which can cause the rapid conversion of Th2 to Th1, thereby increasing the pro-inflammatory factor tumor necrosis factor-α (TNF-α), interleukin-8 (IL- 8) and IL-1β, and reduce IL-6 and other anti-inflammatory factors, thereby exacerbating the inflammatory process and allergic diseases. Some recent studies suggest that children with neonatal jaundice are more likely to develop allergic diseases than those without jaundice, and the incidence is 14.1% higher; early-onset neonatal jaundice is positively correlated with blue light therapy in the occurrence and development of allergic diseases. Therefore, it is of great clinical significance to take protective measures to reduce or delay the occurrence of moderate to severe AD in infants and young children when blue light treatment is required for jaundice in children at high risk of allergies.

At the same time, common adverse reactions of neonatal phototherapy include skin rash, fever, diarrhea, etc., and long-term damage to the DNA of skin cells. In order to avoid damaging the health of infants, it is indeed necessary to further standardize and rationalize phototherapy. Infant functional skin care products have the functions of repairing the skin barrier, moisturizing, and anti-inflammatory, and are important basic treatment methods for children with AD. Studies have pointed out that topical moisturizers should be used as early as possible in the neonatal period to reduce and postpone the occurrence of AD. At present, only sensitive parts such as eyes, external genitalia, or vulva should be covered during phototherapy of newborns. There is no research published on skin protection measures during phototherapy.

In summary, neonatal jaundice and phototherapy due to jaundice are very likely to be related to the occurrence and development of infantile AD, and AD is the earliest allergic disease. The relevant clinical guidelines point out that the early standardized use of infant moisturizing products can reduce the occurrence of moderate to severe AD. . Therefore, this project intends to take the lead in conducting research on skin care for newborns at high risk of allergies who need phototherapy. This study is a randomized controlled study. It intends to randomly provide baby moisturizing product care for allergic high-risk newborns who need phototherapy, and verify skin moisturizing during phototherapy of allergic high-risk newborns through evaluation items such as skin microecology analysis, serum allergy indicators, and AD clinical manifestations. It is an effective measure to delay and reduce the severity of AD in infancy.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Li Jing
  • Phone Number: +86 021-20261026
  • Email: zzhlq3@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 9 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Full-term newborns who were admitted to the hospital with phototherapy were treated with "neonatal hyperbilirubinemia".
  2. Ask about a positive family history of allergic diseases, that is, the parents and siblings are atopic constitutions, including allergic asthma, allergic rhinitis, allergic conjunctivitis and (or) history of AD, as well as a significant increase in IgE.
  3. The guardian voluntarily followed the doctor's guidance for treatment and follow-up during the entire study period, and signed an informed consent form.
  4. Exclude severe heart, brain, lung, kidney disease and fatal congenital malformations.

Exclusion Criteria:

  1. Those who do not meet the selection criteria or meet the exclusion criteria after review.
  2. After enrollment, due to the disease, the jaundice gradually worsened to reach the indications for transfusion therapy.
  3. Other skin diseases other than infant AD were diagnosed during the follow-up period.
  4. Guardians voluntarily withdraw from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Use baby moisturizers in addition to basic skin care and protection during phototherapy.
Combination product: Use baby moisturizers by NeoChine
During continuous phototherapy, use skin basic care and protection in combination with baby moisturizing products, use the whole body twice a day, and the amount of each time is not less than 5 grams.
No Intervention: control group
Only basic skin care and protection during phototherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of using external moisturizing products for infants and young children on the occurrence of moderate to severe AD within 6 months of age.
Time Frame: up to 6 months
The Chinese children's AD diagnostic criteria, combined with the SCORAD score, were used to find the diagnosis and severity of AD in newborns up to 6 months of age, and to compared whether skin care interventions during phototherapy have an effect on delaying and lowering AD.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of external moisturizing products on phototherapy
Time Frame: up to 6 months
The amount of water loss in the epidermis and the water content in the stratum corneum was obtained by measuring the water loss of the skin, compare changes before and after phototherapy, and compare with infants who use baby moisturizing products during phototherapy to see if there is a difference in skin barrier function between the two groups of children.
up to 6 months
The effect of jaundice phototherapy on the skin microecology of allergic high-risk infants
Time Frame: up to 6 months
During the admission and discharge of phototherapy, the skin microbiota metagenomic sequencing was performed by taking skin swabs from the children's forehead.
up to 6 months
The effect of phototherapy on the level of neonatal inflammatory factors
Time Frame: up to 6 months
Detection of serum tumor necrosis factor-α (TNF-α), interleukin-2 (IL-2), IL-6, IL-8 and IL-10 levels
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai First Maternity and Infant Hospital

Investigators

  • Study Director: Li Jing, Shanghai First Maternity and Infant Health Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiFMIH-KS21259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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