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

NCT05178433 | Unknown

• 1 other identifier: ShanghaiFMIH-KS21259
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Jaundice; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6 months

Secondary Outcomes (3)

• The effect of external moisturizing products on phototherapy

  up to 6 months

• The effect of jaundice phototherapy on the skin microecology of allergic high-risk infants

  up to 6 months

• The effect of phototherapy on the level of neonatal inflammatory factors

  up to 6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Combination Product: Use baby moisturizers by NeoChine

control group

NO INTERVENTION

Only basic skin care and protection during phototherapy.

Interventions

Use baby moisturizers by NeoChine COMBINATION_PRODUCT

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.

Experimental group

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Related Publications (14)

• Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1.

  PMID: 32738956 BACKGROUND

• 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.

  PMID: 27616422 BACKGROUND

• Guo Y, Zhang H, Liu Q, Wei F, Tang J, Li P, Han X, Zou X, Xu G, Xu Z, Zong W, Ran Q, Xiao F, Mu Z, Mao X, Ran N, Cheng R, Li M, Li C, Luo Y, Meng C, Zhang X, Xu H, Li J, Tang P, Xiang J, Shen C, Niu H, Li H, Shen J, Ni C, Zhang J, Wang H, Ma L, Bieber T, Yao Z. Phenotypic analysis of atopic dermatitis in children aged 1-12 months: elaboration of novel diagnostic criteria for infants in China and estimation of prevalence. J Eur Acad Dermatol Venereol. 2019 Aug;33(8):1569-1576. doi: 10.1111/jdv.15618. Epub 2019 May 17.

  PMID: 30989708 BACKGROUND

• Yang H, Xiao YZ, Luo XY, Tan Q, Wang H. Diagnostic accuracy of atopy patch tests for food allergy in children with atopic dermatitis aged less than two years. Allergol Immunopathol (Madr). 2014 Jan-Feb;42(1):22-8. doi: 10.1016/j.aller.2012.10.007. Epub 2012 Dec 17.

  PMID: 23253686 BACKGROUND

• Low DW, Jamil A, Md Nor N, Kader Ibrahim SB, Poh BK. Food restriction, nutrition status, and growth in toddlers with atopic dermatitis. Pediatr Dermatol. 2020 Jan;37(1):69-77. doi: 10.1111/pde.14004. Epub 2019 Oct 30.

  PMID: 31667896 BACKGROUND

• Vakharia PP, Silverberg JI. New and emerging therapies for paediatric atopic dermatitis. Lancet Child Adolesc Health. 2019 May;3(5):343-353. doi: 10.1016/S2352-4642(19)30030-6. Epub 2019 Mar 20.

  PMID: 30904349 BACKGROUND

• Nadeem A, Masood A, Siddiqui N. Oxidant--antioxidant imbalance in asthma: scientific evidence, epidemiological data and possible therapeutic options. Ther Adv Respir Dis. 2008 Aug;2(4):215-35. doi: 10.1177/1753465808094971.

  PMID: 19124374 BACKGROUND

• Das RR, Naik SS. Neonatal hyperbilirubinemia and childhood allergic diseases: a systematic review. Pediatr Allergy Immunol. 2015 Feb;26(1):2-11. doi: 10.1111/pai.12281. Epub 2014 Oct 13.

  PMID: 25229699 BACKGROUND

• Procianoy RS, Silveira RC, Fonseca LT, Heidemann LA, Neto EC. The influence of phototherapy on serum cytokine concentrations in newborn infants. Am J Perinatol. 2010 May;27(5):375-9. doi: 10.1055/s-0029-1243311. Epub 2009 Dec 11.

  PMID: 20013604 BACKGROUND

• Beken S, Aydin B, Zencirogglu A, Dilli D, Ozkan E, Dursun A, Okumus N. The effects of phototherapy on eosinophil and eosinophilic cationic protein in newborns with hyperbilirubinemia. Fetal Pediatr Pathol. 2014 Jun;33(3):151-6. doi: 10.3109/15513815.2014.883456. Epub 2014 Feb 14.

  PMID: 24527832 BACKGROUND

• Safar H, Elsary AY. Neonatal Jaundice: The Other Side of the Coin in the Development of Allergy. Am J Perinatol. 2020 Nov;37(13):1357-1363. doi: 10.1055/s-0039-1693697. Epub 2019 Jul 31.

  PMID: 31365932 BACKGROUND

• Wang J, Guo G, Li A, Cai WQ, Wang X. Challenges of phototherapy for neonatal hyperbilirubinemia (Review). Exp Ther Med. 2021 Mar;21(3):231. doi: 10.3892/etm.2021.9662. Epub 2021 Jan 20.

  PMID: 33613704 BACKGROUND

• Horimukai K, Morita K, Narita M, Kondo M, Kitazawa H, Nozaki M, Shigematsu Y, Yoshida K, Niizeki H, Motomura K, Sago H, Takimoto T, Inoue E, Kamemura N, Kido H, Hisatsune J, Sugai M, Murota H, Katayama I, Sasaki T, Amagai M, Morita H, Matsuda A, Matsumoto K, Saito H, Ohya Y. Application of moisturizer to neonates prevents development of atopic dermatitis. J Allergy Clin Immunol. 2014 Oct;134(4):824-830.e6. doi: 10.1016/j.jaci.2014.07.060.

  PMID: 25282564 RESULT

• Cheng R, Zhang H, Zong W, Tang J, Han X, Zhang L, Zhang X, Gu H, Shu Y, Peng G, Huang L, Liu Q, Gao X, Guo Y, Yao Z. Development and validation of new diagnostic criteria for atopic dermatitis in children of China. J Eur Acad Dermatol Venereol. 2020 Mar;34(3):542-548. doi: 10.1111/jdv.15979. Epub 2019 Oct 31.

  PMID: 31568595 RESULT

MeSH Terms

Conditions

Jaundice, Neonatal; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Li Jing

  Shanghai First Maternity and Infant Health Hospital

  STUDY DIRECTOR

Central Study Contacts

Li Jing

CONTACT

+86 021-20261026; zzhlq3@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: January 5, 2022
• Study Start: February 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: June 30, 2024
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share