Skin Lipid Profiles in Term and Preterm Infants

NCT ID: NCT01841268

Last Updated: 2019-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Infants in the UCDMC Neonatal Intensive Care Unit with no congenital or acquired diseases of the skin or cardiovascular system will be enrolled after informed consent has been obtained from their parents. This is an observational study with no intervention. Procedures: At enrollment, 2 weeks and 4 weeks of age, skin lipids will be collected using three methods. First two small pieces of blotting paper (2 cm x 2 cm) will be placed on the infant's skin, one on the left side of the abdomen just above the umbilicus and one on the left inner thigh. The blotting paper will be left in place for 15 seconds and then removed. Second, two adhesive discs will be placed on the skin, one just below the umbilicus and one on the right inner thigh. The discs will be left in place for 30 seconds and then removed. Third, two areas of skin, one on the right side of the abdomen just above the umbilicus and the other on the inner right thigh, will be gently swabbed with sterile cotton swabs (one for each location). The intent is to remove a thin layer of oil/lipid from the skin upon removal of the paper or the adhesive disc or with swabbing without disrupting the skin surface (similar to taking a fingerprint). Blood specimens will be obtained three times, each time 1 ml : once at enrollment, at 2 weeks and the last one at 4 weeks of age, to generate a plasma lipoprotein profile and size distribution (HDL, LDL, VLDL, total cholesterol). For infants that are fed expressed human milk, we will also obtain a sample of mother's milk for analysis of lipid profile (about 2 ml).

Conditions

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Preterm Infants

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Underwood, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis

Davis, California, United States

Site Status

University of California Davis Medical Center NICU

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 195148 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16737871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19675577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17568800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11380152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16962101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20533828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19295613 (View on PubMed)

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.

Reference Type RESULT
PMID: 29076117 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26041675 (View on PubMed)

Related Links

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Other Identifiers

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240869

Identifier Type: -

Identifier Source: org_study_id

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