Skin Maturation in Premature Infants

NCT01619228 | Completed

• 1 other identifier: CCHMC IRB 2011-1840
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 2

Brief Summary

The skin barrier lipids will be lower in premature infants than in full term infants and will become normal over 3-4 months after birth. The higher skin pH in premature infants will be related to an altered lipid composition which will change as the skin acidifies.

Conditions

Premature Birth of Newborn

Keywords

premature infant; neonate; skin maturation; stratum corneum maturation; ontogeny of neonatal skin maturation; sunflower oil; effect of Vitamin B3 on premature skin maturation; skin acidity; stratum corneum barrier integrity; stratum corneum lipid composition; stratum corneum biomarkers; stratum corneum cytokines; stratum corneum structural proteins

Outcome Measures

Primary Outcomes (1)

• Time for premature infants stratum corneum lipid composition to become indistinguishable from composition in healthy full term infants and in comparison to a contralateral site treated with sunflower oil

  Stratum corneum ceramides, sphingoid bases, and free fatty acids in premature infants will be compared with those in full term infants and adults. The composition will be evaluated over six months for premature infants and full term infants and compared to those of adults. Lipid composition is determined from extracts of stratum corneum collected from the skin surface at designated skin sites on each leg. Analyses are conducted using supercritical fluid chromatography and tandem mass spectrometry and reported as total free fatty acids, cholesterol, total ceramides and total sphingoid bases normalized to total protein.

  Until six months after discharge

Secondary Outcomes (1)

• Skin Surface Acidity

  Until six months after discharge

Study Arms (3)

Premature Infants

Infants born at \< 37 weeks gestational age

Full Term Infants

Infants born at equal to or greater than 37 weeks gestational age

Adults

Adults are parents of infants enrolled in the study

Eligibility Criteria

• Age: 24 Weeks - 43 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants and parents of infants who are patients at Cincinnati Children's Hospital Medical Center Neonatal Intensive Care Units including premature and full-term infants

You may qualify if:

• (1) Premature infants of gestational ages 24 to 36.9 weeks or healthy full term infants of gestational age ≥ 37 weeks (2) Premature infants who are patients in the Neonatal Intensive Care Unit of University Hospital (3) Healthy full term infants (who were born at University Hospital (4) Full term infants (≥ 37 weeks gestational age) who were transported to Cincinnati Children's Hospital Medical Center for care after birth (4) Free of congenital conditions known to affect the skin such as epidermolysis bullosa, ichthyosis, trisomy 2 (5) Free of skin infections such as herpes simplex (6) Sufficiently medically stable such that study procedures can be tolerated (7) Parent/guardian willing to provide written informed consent for participation
• Direct admit surgical subjects
• Premature infants of gestational ages 24 to 36.9 weeks
• Full term infants ≥ 37 weeks gestational age
• (2) Infant admitted directly to the Neonatal Intensive Care Unit of Cincinnati Childrens for surgical procedures after delivery (3) Free of congenital conditions known to affect the skin such as epidermolysis bullosa, ichthyosis and trisomy 21 (5) Free of skin infections such as herpes simplex (4) Sufficiently medically stable such that study procedures can be tolerated (5) Parent/guardian willing to provide written informed consent for participation

You may not qualify if:

• Gestational age \< 24 weeks
• Have congenital conditions that affect the skin such as epidermolysis bullosa, ichthyosis, trisomy 21
• Have a skin infection such as herpes simplex
• Judged to be medically unstable such that study procedures cannot be tolerated
• Parent/guardian unwilling to provide written informed consent for participation.
• Direct admit surgical subjects
• Infants ≥ 43 weeks gestational age
• Have congenital conditions known to affect the skin such as epidermolysis bullosa, ichthyosis, trisomy 21
• Have a skin infection such as herpes simplex
• Adult subject controls:
• Parent of an infant enrolled in the study
• Free from skin irritation, rash, scars, wounds or other skin damage in an area of at least 200 cm2 on one volar forearm
• Able to come to the infant's hospital for study measurements on one day when infant measurements are made
• Willing to provide written informed consent for participation
• (1) Not a parent of an infant enrolled in the study (2) Have skin irritation, rash, scars, wounds or other skin damage in an area of at least 200 cm2 on one volar forearm (3) Unable to come to the infant's hospital for study measurements on one day when infant measurements are made (4) Unwilling to provide written informed consent for participation

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Procter and Gamble: collaborator

Study Sites (2)

Cincinnati Childrens Hospital Medical Center Neonatal Intensive Care Unit

Cincinnati, Ohio, 45229, United States

Location

University Hospital Neonatal Intensive Care Unit

Cincinnati, Ohio, 45267, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Full thickness tissue samples are to be collected from subjects who undergo surgery as part of their care and for whom a sample of tissue can be collected.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Marty O Visscher, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 14, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2017
• Last Updated: February 10, 2020

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)