- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01841268
Skin Lipid Profiles in Term and Preterm Infants
2019년 6월 28일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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).
연구 유형
관찰
등록 (실제)
25
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Davis, California, 미국, 95616
- University of California, Davis
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Sacramento, California, 미국, 95817
- University of California Davis Medical Center NICU
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
4주 이하 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Skin Proteome
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mark Underwood, M.D., University of California, Davis
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 5월 1일
기본 완료 (실제)
2016년 12월 1일
연구 완료 (실제)
2016년 12월 1일
연구 등록 날짜
최초 제출
2013년 4월 23일
QC 기준을 충족하는 최초 제출
2013년 4월 25일
처음 게시됨 (추정)
2013년 4월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 6월 28일
마지막으로 확인됨
2019년 6월 1일
추가 정보
이 연구와 관련된 용어
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .