Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Skin Lipid Profiles in Term and Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01841268
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease
Preterm Infants

Detailed Description:
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).

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 25 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Skin Lipid Profiles in Term and Preterm Infants
Study Start Date : May 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Group/Cohort
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.



Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood, epidermal skin cells, breast milk


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841268


Locations
Layout table for location information
United States, California
University of California, Davis
Davis, California, United States, 95616
University of California Davis Medical Center NICU
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Layout table for investigator information
Principal Investigator: Mark Underwood, M.D. University of California, Davis

Additional Information:
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01841268     History of Changes
Other Study ID Numbers: 240869
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Keywords provided by University of California, Davis:
premature, preterm, premie, skin
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications