Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01841268
Other study ID # 240869
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2010
Est. completion date December 2016

Study information

Verified date June 2019
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 4 Weeks
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of California, Davis Davis California
United States University of California Davis Medical Center NICU Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (9)

Agren J, Sjörs G, Sedin G. Ambient humidity influences the rate of skin barrier maturation in extremely preterm infants. J Pediatr. 2006 May;148(5):613-7. — View Citation

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. — View Citation

Feingold KR, Schmuth M, Elias PM. The regulation of permeability barrier homeostasis. J Invest Dermatol. 2007 Jul;127(7):1574-6. — View Citation

Holleran WM, Takagi Y, Uchida Y. Epidermal sphingolipids: metabolism, function, and roles in skin disorders. FEBS Lett. 2006 Oct 9;580(23):5456-66. Epub 2006 Sep 1. Review. — View Citation

Jiang YJ, Barish G, Lu B, Evans RM, Crumrine D, Schmuth M, Elias PM, Feingold KR. PPARd 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. — View Citation

Nilsson GE. Measurement of water exchange through skin. Med Biol Eng Comput. 1977 May;15(3):209-18. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Skin Proteome Premie infant skin proteome changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life. Change between 0, 2, and 4 weeks
Primary Skin Lipidome Premie infant skin lipidome changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life Changes between 0, 2, and 4 weeks
Primary Skin Microbiota Premie infant skin microbiota changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life Changes between 1, 2, and 4 weeks
Primary Skin Sebum Premie infant skin sebum changes will be determined between 0 weeks (less than 5 days of life), 2 weeks, and 4 weeks of life Changes between 0, 2, and 4 weeks
Primary Breast Milk Lipidome 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 Changes between 0, 2, and 4 weeks
Primary Breast Milk Fatty Acids 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 Changes between 0, 2, and 4 weeks
Primary Plasma Lipoprotein Profile(HDL, LDL, VLDL, total cholesterol) 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 Changes between 0, 2, and 4 weeks
Primary Plasma Lipoprotein Size Distribution(HDL, LDL, VLDL, total cholesterol) 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 Changes between 0, 2, and 4 weeks
Primary Plasma Fatty Acid Analysis 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 Changes between 0, 2, and 4 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02159534 - Primebrain Stimulation N/A
Recruiting NCT01813682 - Effect of Iron-fortified TPN on Preterm Infants Anemia N/A
Not yet recruiting NCT01615523 - Executive Function in Preterm Born Children: An Integrative Approach From Genetics to Brain Function N/A
Completed NCT02103777 - High Versus Low Dose of Caffeine for Apnea of Prematurity Phase 3
Recruiting NCT06201962 - Effect of Massage and Foot Reflexology on Newborns' Sleep N/A
Completed NCT05230706 - Light/Dark Cycle Promotes Weight Gain in Preterm Infants N/A
Recruiting NCT05138276 - Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates Early Phase 1
Terminated NCT01430832 - Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
Not yet recruiting NCT02872350 - Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA. N/A
Recruiting NCT01786759 - Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion Phase 4
Completed NCT00838474 - The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants N/A
Completed NCT05656677 - Parental Involvement in Pain Reducing Measures N/A
Active, not recruiting NCT01487187 - The Effect of Cord Milking on Hemodynamic Status of Preterm Infants N/A
Completed NCT00838188 - Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk N/A
Recruiting NCT03121781 - Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula N/A
Completed NCT02770976 - Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants N/A
Not yet recruiting NCT00320840 - Internal and Familial Resources and Motherhood. Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants N/A
Completed NCT00707837 - Nutritional Study in Preterm Infants Phase 3
Completed NCT01083303 - Weaning Preterm Infants at 1500 Grams From Incubators N/A
Recruiting NCT03631264 - The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants. N/A

External Links