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Completed

NCT Number: NCT01841268

Skin Lipid Profiles in Term and Preterm Infants

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.

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Key information

Conditions

Preterm Infants Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 4 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Davis, Davis, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Skin Proteome

    Time frame: Change between 0, 2, and 4 weeks

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

  2. Skin Lipidome

    Time frame: Changes between 0, 2, and 4 weeks

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

  3. Skin Microbiota

    Time frame: Changes between 1, 2, and 4 weeks

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

  4. Skin Sebum

    Time frame: Changes between 0, 2, and 4 weeks

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

  5. Breast Milk Lipidome

    Time frame: Changes between 0, 2, and 4 weeks

    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

  6. Breast Milk Fatty Acids

    Time frame: Changes between 0, 2, and 4 weeks

    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

  7. Plasma Lipoprotein Profile(HDL, LDL, VLDL, total cholesterol)

    Time frame: Changes between 0, 2, and 4 weeks

    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

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

    Time frame: Changes between 0, 2, and 4 weeks

    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

  9. Plasma Fatty Acid Analysis

    Time frame: Changes between 0, 2, and 4 weeks

    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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2013
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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