Skin Maturation in Premature Infants
Completed
Conditions studied: Premature Birth of Newborn
In brief
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.
Key facts
- Study ID
- NCT01619228
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 107
- Starts
- 2012-04-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2020-02-10
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.
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
- Inclusion Criteria:
- 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
- Exclusion Criteria:
- 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:
- Inclusion Criteria:
- 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
- Exclusion Criteria:
- (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
Where it is running
- Cincinnati Childrens Hospital Medical Center Neonatal Intensive Care Unit — Cincinnati, Ohio, United States
- University Hospital Neonatal Intensive Care Unit — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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