Skin Lipid Profiles in Term and Preterm Infants

NCT01841268 | Completed

• 1 other identifier: 240869
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to compare the skin lipid and protein composition between term and premature infants and determine how the skin composition changes over the first four weeks of life. The investigators hope to elucidate the unique characteristics of premature skin by measuring the lipid and protein content in skin, how it changes during the first month of life, and how it varies with formula feeding versus breast feeding. Additionally, the investigators will study the relationships among diet, skin composition and plasma lipids in premature infants over the first four weeks of life.

Conditions

Preterm Infants

Keywords

premature, preterm, premie, skin

Outcome Measures

Primary Outcomes (9)

• Skin Proteome

  Premie infant skin proteome changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life.

  Change between 0, 2, and 4 weeks

• Skin Lipidome

  Premie infant skin lipidome changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life

  Changes between 0, 2, and 4 weeks

• Skin Microbiota

  Premie infant skin microbiota changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life

  Changes between 1, 2, and 4 weeks

• Skin Sebum

  Premie infant skin sebum changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life

  Changes between 0, 2, and 4 weeks

• Breast Milk Lipidome

  Mothers of premie infants will have their breast milk lipidome analyzed for changes between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life

  Changes between 0, 2, and 4 weeks

• Breast Milk Fatty Acids

  Mothers of premie infants will have their breast milk fatty acids analyzed for changes between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life

  Changes between 0, 2, and 4 weeks

• Plasma Lipoprotein Profile(HDL, LDL, VLDL, total cholesterol)

  Premie infant lipoprotein (HDL, LDL, VLDL, total cholesterol) profile changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life

  Changes between 0, 2, and 4 weeks

• Plasma Lipoprotein Size Distribution(HDL, LDL, VLDL, total cholesterol)

  Premie infant lipoprotein (HDL, LDL, VLDL, total cholesterol) size distribution changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life

  Changes between 0, 2, and 4 weeks

• Plasma Fatty Acid Analysis

  Premie infant plasma fatty acid analysis changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life

  Changes between 0, 2, and 4 weeks

Study Arms (2)

Preterm Infants

Infants born prematurely will have their skin, sebum, microbiota, blood, and mother's breast milk analyzed for changes between 0, 2, and 4 weeks of life.

Term Infants, Control

Term infants enrolled in the UC Davis Lactation Study (protocol # 216198) will serve as the control group for this study; they will have their skin, sebum, microbiota, and mother's breast milk analyzed for changes between 0, 2, and 4 weeks of life.

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn infants in the NICU at UCDMC. 20 neonates will be enrolled, 5 in each of the following gestational age categories: 23-27 weeks, 28-32 weeks, 33-36 weeks, \>36 weeks. Infants will be involved in the study from enrollment until 4 weeks of age or until discharge, whichever comes first.

You may qualify if:

• infants who are likely to be inpatients in the NICU for at least 4 weeks

You may not qualify if:

• congenital or acquired skin disease,
• cyanotic congenital heart disease,
• neonates that are not viable and
• those with lethal anomalies such as anencephaly, trisomy 13, trisomy 18, renal agenesis

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (2)

University of California, Davis

Davis, California, 95616, United States

Location

University of California Davis Medical Center NICU

Sacramento, California, 95817, United States

Location

Related Publications (10)

• Nilsson GE. Measurement of water exchange through skin. Med Biol Eng Comput. 1977 May;15(3):209-18. doi: 10.1007/BF02441040. No abstract available.

  PMID: 195148 BACKGROUND

• Agren J, Sjors G, Sedin G. Ambient humidity influences the rate of skin barrier maturation in extremely preterm infants. J Pediatr. 2006 May;148(5):613-7. doi: 10.1016/j.jpeds.2005.11.027.

  PMID: 16737871 BACKGROUND

• Jiang YJ, Barish G, Lu B, Evans RM, Crumrine D, Schmuth M, Elias PM, Feingold KR. PPARdelta activation promotes stratum corneum formation and epidermal permeability barrier development during late gestation. J Invest Dermatol. 2010 Feb;130(2):511-9. doi: 10.1038/jid.2009.245. Epub 2009 Aug 13.

  PMID: 19675577 BACKGROUND

• Feingold KR, Schmuth M, Elias PM. The regulation of permeability barrier homeostasis. J Invest Dermatol. 2007 Jul;127(7):1574-6. doi: 10.1038/sj.jid.5700774.

  PMID: 17568800 BACKGROUND

• Weerheim A, Ponec M. Determination of stratum corneum lipid profile by tape stripping in combination with high-performance thin-layer chromatography. Arch Dermatol Res. 2001 Apr;293(4):191-9. doi: 10.1007/s004030100212.

  PMID: 11380152 BACKGROUND

• Holleran WM, Takagi Y, Uchida Y. Epidermal sphingolipids: metabolism, function, and roles in skin disorders. FEBS Lett. 2006 Oct 9;580(23):5456-66. doi: 10.1016/j.febslet.2006.08.039. Epub 2006 Sep 1.

  PMID: 16962101 BACKGROUND

• Bennett K, Callard R, Heywood W, Harper J, Jayakumar A, Clayman GL, Di WL, Mills K. New role for LEKTI in skin barrier formation: label-free quantitative proteomic identification of caspase 14 as a novel target for the protease inhibitor LEKTI. J Proteome Res. 2010 Aug 6;9(8):4289-94. doi: 10.1021/pr1003467.

  PMID: 20533828 BACKGROUND

• Rice RH, Rocke DM, Tsai HS, Silva KA, Lee YJ, Sundberg JP. Distinguishing mouse strains by proteomic analysis of pelage hair. J Invest Dermatol. 2009 Sep;129(9):2120-5. doi: 10.1038/jid.2009.52. Epub 2009 Mar 19.

  PMID: 19295613 BACKGROUND

• Scoble JA, Smilowitz JT, Argov-Argaman N, German JB, Underwood MA. Plasma Lipoprotein Particle Subclasses in Preterm Infants. Am J Perinatol. 2018 Mar;35(4):369-379. doi: 10.1055/s-0037-1607347. Epub 2017 Oct 26.

  PMID: 29076117 RESULT

• Spevacek AR, Smilowitz JT, Chin EL, Underwood MA, German JB, Slupsky CM. Infant Maturity at Birth Reveals Minor Differences in the Maternal Milk Metabolome in the First Month of Lactation. J Nutr. 2015 Aug;145(8):1698-708. doi: 10.3945/jn.115.210252. Epub 2015 Jun 3.

  PMID: 26041675 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Blood, epidermal skin cells, breast milk

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mark Underwood, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 26, 2013
• Study Start: May 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 2, 2019

Record last verified: 2019-06

Locations

US (2)