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- Klinische proef NCT01841268
Skin Lipid Profiles in Term and Preterm Infants
28 juni 2019 bijgewerkt door: University of California, Davis
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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).
Studietype
Observationeel
Inschrijving (Werkelijk)
25
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Davis, California, Verenigde Staten, 95616
- University of California, Davis
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Sacramento, California, Verenigde Staten, 95817
- University of California Davis Medical Center NICU
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Niet ouder dan 4 weken (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Skin Proteome
Tijdsspanne: Change between 0, 2, and 4 weeks
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Premie infant skin proteome changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life.
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Change between 0, 2, and 4 weeks
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Skin Lipidome
Tijdsspanne: Changes between 0, 2, and 4 weeks
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Premie infant skin lipidome changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life
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Changes between 0, 2, and 4 weeks
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Skin Microbiota
Tijdsspanne: Changes between 1, 2, and 4 weeks
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Premie infant skin microbiota changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life
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Changes between 1, 2, and 4 weeks
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Skin Sebum
Tijdsspanne: Changes between 0, 2, and 4 weeks
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Premie infant skin sebum changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life
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Changes between 0, 2, and 4 weeks
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Breast Milk Lipidome
Tijdsspanne: Changes between 0, 2, and 4 weeks
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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
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Changes between 0, 2, and 4 weeks
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Breast Milk Fatty Acids
Tijdsspanne: Changes between 0, 2, and 4 weeks
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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
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Changes between 0, 2, and 4 weeks
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Plasma Lipoprotein Profile(HDL, LDL, VLDL, total cholesterol)
Tijdsspanne: Changes between 0, 2, and 4 weeks
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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
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Changes between 0, 2, and 4 weeks
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Plasma Lipoprotein Size Distribution(HDL, LDL, VLDL, total cholesterol)
Tijdsspanne: Changes between 0, 2, and 4 weeks
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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
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Changes between 0, 2, and 4 weeks
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Plasma Fatty Acid Analysis
Tijdsspanne: Changes between 0, 2, and 4 weeks
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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
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Changes between 0, 2, and 4 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mark Underwood, M.D., University of California, Davis
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2010
Primaire voltooiing (Werkelijk)
1 december 2016
Studie voltooiing (Werkelijk)
1 december 2016
Studieregistratiedata
Eerst ingediend
23 april 2013
Eerst ingediend dat voldeed aan de QC-criteria
25 april 2013
Eerst geplaatst (Schatting)
26 april 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 juli 2019
Laatste update ingediend die voldeed aan QC-criteria
28 juni 2019
Laatst geverifieerd
1 juni 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 240869
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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