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

Primary Purpose

Neonatal Jaundice, Atopic Dermatitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Use baby moisturizers by NeoChine
Sponsored by
Shanghai First Maternity and Infant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Jaundice

Eligibility Criteria

37 Weeks - 42 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental group

    control group

    Arm Description

    Use baby moisturizers in addition to basic skin care and protection during phototherapy.

    Only basic skin care and protection during phototherapy.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    The effect of external moisturizing products on phototherapy
    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.
    The effect of jaundice phototherapy on the skin microecology of allergic high-risk infants
    During the admission and discharge of phototherapy, the skin microbiota metagenomic sequencing was performed by taking skin swabs from the children's forehead.
    The effect of phototherapy on the level of neonatal inflammatory factors
    Detection of serum tumor necrosis factor-α (TNF-α), interleukin-2 (IL-2), IL-6, IL-8 and IL-10 levels

    Full Information

    First Posted
    November 22, 2021
    Last Updated
    January 13, 2022
    Sponsor
    Shanghai First Maternity and Infant Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05178433
    Brief Title
    Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate and Severe Infants
    Official Title
    Randomized Controlled Study of Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate and Severe Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2022 (Anticipated)
    Primary Completion Date
    September 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai First Maternity and Infant Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neonatal Jaundice, Atopic Dermatitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Use baby moisturizers in addition to basic skin care and protection during phototherapy.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Only basic skin care and protection during phototherapy.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Use baby moisturizers by NeoChine
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    up to 6 months
    Secondary Outcome Measure Information:
    Title
    The effect of external moisturizing products on phototherapy
    Description
    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.
    Time Frame
    up to 6 months
    Title
    The effect of jaundice phototherapy on the skin microecology of allergic high-risk infants
    Description
    During the admission and discharge of phototherapy, the skin microbiota metagenomic sequencing was performed by taking skin swabs from the children's forehead.
    Time Frame
    up to 6 months
    Title
    The effect of phototherapy on the level of neonatal inflammatory factors
    Description
    Detection of serum tumor necrosis factor-α (TNF-α), interleukin-2 (IL-2), IL-6, IL-8 and IL-10 levels
    Time Frame
    up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    37 Weeks
    Maximum Age & Unit of Time
    42 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Full-term newborns who were admitted to the hospital with phototherapy were treated with "neonatal hyperbilirubinemia". 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. The guardian voluntarily followed the doctor's guidance for treatment and follow-up during the entire study period, and signed an informed consent form. Exclude severe heart, brain, lung, kidney disease and fatal congenital malformations. Exclusion Criteria: Those who do not meet the selection criteria or meet the exclusion criteria after review. After enrollment, due to the disease, the jaundice gradually worsened to reach the indications for transfusion therapy. Other skin diseases other than infant AD were diagnosed during the follow-up period. Guardians voluntarily withdraw from the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Li Jing
    Phone
    +86 021-20261026
    Email
    zzhlq3@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li Jing
    Organizational Affiliation
    Shanghai First Maternity and Infant Health Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    32738956
    Citation
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    Drucker AM, Wang AR, Li WQ, Sevetson E, Block JK, Qureshi AA. The Burden of Atopic Dermatitis: Summary of a Report for the National Eczema Association. J Invest Dermatol. 2017 Jan;137(1):26-30. doi: 10.1016/j.jid.2016.07.012. Epub 2016 Sep 8.
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    Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate and Severe Infants

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