Mother - Newborn Observational Study

NCT04759924 | Completed

• 1 other identifier: CRC-SP-AC-38
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnancy leads to a number of skin changes but empirical evidence about the structural and functional changes of the skin is scarce. Findings on skin structure and function in newborns and children in the first year of life reveal a rapid skin maturation after birth, but evidence indicates, that in particular water-holding and transport mechanisms are very different to adults in the first year in life. The most important open question is whether and how the maternal cutaneous properties predict the skin function of their children. This is especially relevant for the skin microbiome, because it closely interacts with the host and is assumed to play a role in many skin diseases. Therefore, the objective of this study is the description of characteristics of skin and hair structure and skin function of pregnant women and their newborns during pregnancy and for both in the first six months after delivery. In addition, we investigate associations of the mother's and their newborns skin microbiomes, and changes thereof in the newborns within the first six months of life. The study has a descriptive, exploratory, longitudinal design. We will recruit pregnant females between 18 to 45 years old using advertisement campaigns, study information material in the waiting areas of their gynecologists, in pregnancy preparation services and in hospital's outpatient services. If they are interested and fulfill the inclusion criteria, they are invited to participate. Taking into account an assumed dropout rate of about 30%, a final sample of n = 100 women is expected. A detailed dermatological examination and general medical condition are documented. Non-invasive, standardized skin and hair physiological and skin microbiome measurements are performed during the visits. Baseline is scheduled during pregnancy until late 4 weeks before delivery. Follow-up visits are scheduled 4 weeks and 6 months after birth for mothers and newborns. Descriptive statistical methods will be calculated for frequencies and associations over time depending on scale levels of the measurements. In our longitudinal study, we will characterize a broad range of individual and environmental characteristics of mothers and their newborns to evaluate interrelationships with skin parameters and their changes over the period of at least 8 months. Considering these multiple variables and levels together will allow a deeper understanding of the complex interrelationship of the newborns skin maturation.

Conditions

Skin Microbiome

Keywords

descriptive longitudinal study; skin structure; skin function; skin microbiome; hair growth; pregnancy; newborn

Outcome Measures

Primary Outcomes (8)

• Change from baseline stratum corneum hydratation (SCH) at 4 weeks and 6 months after delivery

  measurement of skin hydration: arbitrary units 0-120 , whereas higher readings indicate higher stratum corneum hydration

  baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery

• Change from baseline Skin surface pH at 4 weeks and 6 months after delivery

  Skin pH-meter measurement (range from 4 to 7,5)

  baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery

• Change from baseline Transepidermal water loss (TEWL ) at 4 weeks and 6 months after delivery

  Transepidermal waterloss through the stratum corneum in g per hour per m2 (range: 0,0-60,0 g/m2/h)

  baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery

• Change from baseline Skin stiffness and elasticity at 4 weeks and 6 months after delivery

  total extensibility (Uf, mm), Structural elasticity Uf) of the skin (0,00-0,50 Uf in mm/degree)

  baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery

• Change from baseline Epidermal thickness at 4 weeks and 6 months after delivery

  Standardized images via Optical coherence tomography (OCT) measured in mm

  baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery

• Change from baseline Skin surface topography at 4 weeks and 6 months after delivery

  Standardized images via Visioscan * RA (arithmetic mean roughness) in µm * RZ (arithmetic mean roughness from five sampling length) in µm

  baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery

• Change from baseline Skin microbiome at 4 weeks and 6 months after delivery

  Bacterial diversity Relative abundance of phylotypes (operational taxonomic units, (OTUs)

  baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery

• Change from baseline Hair growth at 4 weeks and 6 months after delivery

  Measurement of Hair thickness

  baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women and their newborns

You may qualify if:

• written informed consent
• clinically healthy skin and hair appearance
• being free of any dermatological condition
• acceptance to abstain from sunbathing
• acceptance to abstain from solarium
• agreement to use the same skin cleaning and caring procedures during the study

You may not qualify if:

• regular smoking
• regular alcohol intake
• any dermatological condition or skin affection which may interfere with the study assessments (psoriasis, atopic dermatitis or other lesions at the investigational sites)
• clinically significant, possibly unstable medical conditions due to gravidity such as gestosis, eclampsia or thrombosis.
• Criteria related to treatments and products such as current topical or systemic treatment possibly affecting the skin, (diuretics, cholesterol-lowering drugs, hormones) during past four weeks

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité-Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (24)

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  PMID: 30130786 BACKGROUND

• Muallem MM, Rubeiz NG. Physiological and biological skin changes in pregnancy. Clin Dermatol. 2006 Mar-Apr;24(2):80-3. doi: 10.1016/j.clindermatol.2005.10.002.

  PMID: 16487877 BACKGROUND

• Vora RV, Gupta R, Mehta MJ, Chaudhari AH, Pilani AP, Patel N. Pregnancy and skin. J Family Med Prim Care. 2014 Oct-Dec;3(4):318-24. doi: 10.4103/2249-4863.148099.

  PMID: 25657937 BACKGROUND

• Panicker VV, Riyaz N, Balachandran PK. A clinical study of cutaneous changes in pregnancy. J Epidemiol Glob Health. 2017 Mar;7(1):63-70. doi: 10.1016/j.jegh.2016.10.002. Epub 2016 Nov 19.

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• Ciechanowicz P, Sikora M, Taradaj K, Ruta A, Rakowska A, Kociszewska-Najman B, Wielgos M, Rudnicka L. Skin changes during pregnancy. Is that an important issue for pregnant women? Ginekol Pol. 2018;89(8):449-52. doi: 10.5603/GP.a2018.0077.

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• Martins-Costa GM, Bakos R. Total Body Photography and Sequential Digital Dermoscopy in Pregnant Women. Dermatol Pract Concept. 2019 Apr 30;9(2):126-131. doi: 10.5826/dpc.0902a08. eCollection 2019 Apr.

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• Thom E. Pregnancy and the hair growth cycle: anagen induction against hair growth disruption using Nourkrin(R) with Marilex(R) , a proteoglycan replacement therapy. J Cosmet Dermatol. 2017 Sep;16(3):421-427. doi: 10.1111/jocd.12286. Epub 2016 Sep 23.

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• Pierard-Franchimont C, Pierard GE. Alterations in hair follicle dynamics in women. Biomed Res Int. 2013;2013:957432. doi: 10.1155/2013/957432. Epub 2013 Dec 24.

  PMID: 24455742 BACKGROUND

• Boyer G, Lachmann N, Bellemere G, De Belilovsky C, Baudouin C. Effects of pregnancy on skin properties: A biomechanical approach. Skin Res Technol. 2018 Nov;24(4):551-556. doi: 10.1111/srt.12465. Epub 2018 Feb 26.

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• Ludriksone L, Garcia Bartels N, Kanti V, Blume-Peytavi U, Kottner J. Skin barrier function in infancy: a systematic review. Arch Dermatol Res. 2014 Sep;306(7):591-9. doi: 10.1007/s00403-014-1458-6. Epub 2014 Mar 5.

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• Nikolovski J, Stamatas GN, Kollias N, Wiegand BC. Barrier function and water-holding and transport properties of infant stratum corneum are different from adult and continue to develop through the first year of life. J Invest Dermatol. 2008 Jul;128(7):1728-36. doi: 10.1038/sj.jid.5701239. Epub 2008 Jan 17.

  PMID: 18200056 BACKGROUND

• Visscher MO, Adam R, Brink S, Odio M. Newborn infant skin: physiology, development, and care. Clin Dermatol. 2015 May-Jun;33(3):271-80. doi: 10.1016/j.clindermatol.2014.12.003. Epub 2014 Dec 8.

  PMID: 25889127 BACKGROUND

• Oranges T, Dini V, Romanelli M. Skin Physiology of the Neonate and Infant: Clinical Implications. Adv Wound Care (New Rochelle). 2015 Oct 1;4(10):587-595. doi: 10.1089/wound.2015.0642.

  PMID: 26487977 BACKGROUND

• Hughes-Formella B, Wunderlich O, Williams R, Fernandez J, Kim YZ, Wigger-Alberti W, Pecquet S, Moodycliffe A. Comparison of Skin Structural and Functional Parameters in Well-Nourished and Moderately Undernourished Infants. Skin Pharmacol Physiol. 2019;32(4):212-223. doi: 10.1159/000499434. Epub 2019 Jun 5.

  PMID: 31167217 BACKGROUND

• Fluhr JW, Darlenski R. Skin Surface pH in Newborns: Origin and Consequences. Curr Probl Dermatol. 2018;54:26-32. doi: 10.1159/000489515. Epub 2018 Aug 21.

  PMID: 30130770 BACKGROUND

• Findley K, Grice EA. The skin microbiome: a focus on pathogens and their association with skin disease. PLoS Pathog. 2014 Nov 13;10(10):e1004436. doi: 10.1371/journal.ppat.1004436. eCollection 2014 Oct. No abstract available.

  PMID: 25393405 BACKGROUND

• Capone KA, Dowd SE, Stamatas GN, Nikolovski J. Diversity of the human skin microbiome early in life. J Invest Dermatol. 2011 Oct;131(10):2026-32. doi: 10.1038/jid.2011.168. Epub 2011 Jun 23.

  PMID: 21697884 BACKGROUND

• Dominguez-Bello MG, Costello EK, Contreras M, Magris M, Hidalgo G, Fierer N, Knight R. Delivery mode shapes the acquisition and structure of the initial microbiota across multiple body habitats in newborns. Proc Natl Acad Sci U S A. 2010 Jun 29;107(26):11971-5. doi: 10.1073/pnas.1002601107. Epub 2010 Jun 21.

  PMID: 20566857 BACKGROUND

• Costello EK, Carlisle EM, Bik EM, Morowitz MJ, Relman DA. Microbiome assembly across multiple body sites in low-birthweight infants. mBio. 2013 Oct 29;4(6):e00782-13. doi: 10.1128/mBio.00782-13.

  PMID: 24169577 BACKGROUND

• Younge NE, Araujo-Perez F, Brandon D, Seed PC. Early-life skin microbiota in hospitalized preterm and full-term infants. Microbiome. 2018 May 31;6(1):98. doi: 10.1186/s40168-018-0486-4.

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• Zhu T, Liu X, Kong FQ, Duan YY, Yee AL, Kim M, Galzote C, Gilbert JA, Quan ZX. Age and Mothers: Potent Influences of Children's Skin Microbiota. J Invest Dermatol. 2019 Dec;139(12):2497-2505.e6. doi: 10.1016/j.jid.2019.05.018. Epub 2019 Aug 13.

  PMID: 31420081 BACKGROUND

• Lehtimaki J, Karkman A, Laatikainen T, Paalanen L, von Hertzen L, Haahtela T, Hanski I, Ruokolainen L. Patterns in the skin microbiota differ in children and teenagers between rural and urban environments. Sci Rep. 2017 Mar 31;7:45651. doi: 10.1038/srep45651.

  PMID: 28361981 BACKGROUND

• Manus MB, Kuthyar S, Perroni-Maranon AG, Nunez-de la Mora A, Amato KR. Infant Skin Bacterial Communities Vary by Skin Site and Infant Age across Populations in Mexico and the United States. mSystems. 2020 Nov 3;5(6):e00834-20. doi: 10.1128/mSystems.00834-20.

  PMID: 33144313 BACKGROUND

• Wilborn D, Kottner J, Hillmann K, Xu S, Konietschke F, Blume-Peytavi U. Interrelationships between Skin Structure, Function, and Microbiome of Pregnant Females and Their Newborns: Study Protocol for a Prospective Cohort Study. Dermatol Res Pract. 2021 Nov 17;2021:4163705. doi: 10.1155/2021/4163705. eCollection 2021.

  PMID: 34840564 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Swab of the skin microbiome

Study Officials

• Ulrike Blume-Peytavi, Prof. MD

  Charité Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Research Center for Hair and Skin Science

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 18, 2021
• Study Start: March 1, 2021
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)