Neonatal JaundiceNCT05178433
Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate and Severe Infants
A study testing Use baby moisturizers by NeoChine in people with Neonatal Jaundice and Atopic Dermatitis, run by Shanghai First Maternity and Infant Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Jaundice, Atopic Dermatitis
- What is being tested?
- Use baby moisturizers by NeoChine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neonatal Jaundice, Atopic Dermatitis
- Being tested
- Use baby moisturizers by NeoChine
- Medical subject headings
- Jaundice, Neonatal, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use baby moisturizers by NeoChineCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Use baby moisturizers in addition to basic skin care and protection during phototherapy. Receives: Combination Product: Use baby moisturizers by NeoChine |
| control group | No intervention | Only basic skin care and protection during phototherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (3)
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.
Measured: up to 6 months
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.
Measured: up to 6 months
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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Jing, Study director, Shanghai First Maternity and Infant Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178433
- Sponsor's protocol ID
- ShanghaiFMIH-KS21259
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1.
PubMed 32738956Drucker 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.
PubMed 27616422Guo 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.
PubMed 30989708Yang 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.
PubMed 23253686Low 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.
PubMed 31667896Vakharia 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.
PubMed 30904349Nadeem 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.
PubMed 19124374Das 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.
PubMed 25229699Procianoy 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.
PubMed 20013604Beken 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.
PubMed 24527832Safar 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.
PubMed 31365932Wang 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.
PubMed 33613704Horimukai 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.
PubMed 25282564Cheng 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.
PubMed 31568595
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate and Severe Infants
- ClinicalTrials.gov ID
- NCT05178433
- Acronym / sponsor ID
- ShanghaiFMIH-KS21259
- Conditions
- Neonatal Jaundice, Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Combination Product: Use baby moisturizers by NeoChineUse baby moisturizers in addition to basic skin care and protection during phototherapy. |
| control group | No intervention | –Only basic skin care and protection during phototherapy. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use baby moisturizers by NeoChineDuring 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. | Combination product | Experimental group |
Primary outcome
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.
3 secondary outcomes
The effect of external moisturizing products on phototherapy
Time frame: up to 6 months
The effect of jaundice phototherapy on the skin microecology of allergic high-risk infants
Time frame: up to 6 months
The effect of phototherapy on the level of neonatal inflammatory factors
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Background: PubMed 32738956Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1.
- Background: PubMed 27616422Drucker 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.
- Background: PubMed 30989708Guo 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.
- Background: PubMed 23253686Yang 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.
- Background: PubMed 31667896Low 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.
- Background: PubMed 30904349Vakharia 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.
- Background: PubMed 19124374Nadeem 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.
- Background: PubMed 25229699Das 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.
- Background: PubMed 20013604Procianoy 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.
- Background: PubMed 24527832Beken 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.
- Background: PubMed 31365932Safar 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.
- Background: PubMed 33613704Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Jing study director
Shanghai First Maternity and Infant Health Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Use baby moisturizers by NeoChine in people with Neonatal Jaundice and Atopic Dermatitis, run by Shanghai First Maternity and Infant Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Jing (+86 021-20261026, zzhlq3@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05178433, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.