Skin Maturation in Premature Infants

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01619228
First received: June 4, 2012
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Prematurity
Other: sunflower oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Ontogeny of Skin Barrier Maturation in Premature Infants

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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 [ Time Frame: Until six months after discharge ] [ Designated as safety issue: No ]
    We hypothesize that the stratum corneum ceramides, sphingoid bases, and free fatty acids will be lower in premature infants than in full term infants and adults and will normalize over six months post birth. 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.


Secondary Outcome Measures:
  • Skin Surface pH [ Time Frame: Until six months after discharge ] [ Designated as safety issue: No ]
    We hypothesize that the increased skin surface pH in premature infants will be related to the altered lipid composition and which will normalize upon acidification of the stratum corneum. An acidic skin surface is necessary for the effective functioning of enzymes in stratum formation and integrity and for bacterial homeostasis, skin colonization and inhibition of pathogenic bacteria. In VLBW infants, skin pH varies with gestational age and is higher for a longer time compared with full term infants.


Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunflower oil
The assigned leg will be treated with high linoleate sunflower oil (Cargill, Incorporated, Minneapolis, MN) twice a day (approximately 12 hour intervals) by the premature infant's caregiver until discharge. The amount will be 1.2 - 1.5 g per kilogram body weight.
Other: sunflower oil
The assigned leg will be treated with high linoleate sunflower oil (Cargill, Incorporated, Minneapolis, MN) twice a day (approximately 12 hour intervals) by the premature infant's caregiver until discharge. The amount will be 1.2 - 1.5 g per kilogram body weight.
Other Names:
  • sunflower seed oil
  • linoleic acid
No Intervention: untreated
The contralateral site (leg) will not be treated.

Detailed Description:

Premature infants have a poor epidermal barrier with few cornified layers, putting them at significant risk for increased permeability to external agents, skin compromise, high water loss and infection. While the skin develops rapidly after birth upon exposure to the dry environment, the ontogeny of the skin maturation and the time to a fully functional and protective stratum corneum (SC) barrier is largely unknown. The impact of a poor skin barrier on nosocomial infections and the morbidity associated with prematurity is not well defined. The purpose is to evaluate skin barrier maturation in premature infants compared to full term infants. 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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 34 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Premature infants of gestational ages 24 to 33 weeks or healthy full term infants of gestational age > 37 weeks
  2. Premature infants who are patients in the NICU of University Hospital
  3. Healthy full term infants who were born at University Hospital
  4. Free of congenital skin anomalies such as epidermolysis bullosa
  5. Sufficiently medically stable such that study procedures can be tolerated
  6. Parent/guardian willing to provide written informed consent for participation

Direct admit surgical subjects

Inclusion Criteria:

  1. Premature infants of gestational ages 24 to 36 weeks
  2. Infant admitted directly to the NICU of Cincinnati Childrens for surgical procedures after delivery
  3. Free of congenital skin anomalies such as epidermolysis bullosa
  4. Sufficiently medically stable such that study procedures can be tolerated
  5. Parent/guardian willing to provide written informed consent for participation

Exclusion Criteria:

  1. Gestational age < 24 weeks
  2. For premature infants, gestational age ≥ 34 weeks
  3. Full term infants requiring admission to the NICU
  4. Have congenital skin anomalies such as epidermolysis bullosa
  5. Judged to be medically unstable such that study procedures cannot be tolerated
  6. Parent/guardian unwilling to provide written informed consent for participation.

Direct admit surgical subjects

Exclusion Criteria:

  1. Infants > 36 weeks gestational age
  2. Have congenital skin anomalies such as epidermolysis bullosa
  3. Admitted to the NICU of CCHMC for surgical procedures but who did not participate in the ontogeny phase where skin evaluations were conducted

Adult subject controls:

Inclusion Criteria:

  1. Parent of an infant enrolled in the study
  2. Free from skin irritation, rash, scars, wounds or other skin damage in an area of at least 200 cm2 on one volar forearm
  3. Able to come to the infant's hospital for study measurements on one day when infant measurements are made
  4. 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

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  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619228

Locations
United States, Ohio
University Hospital Neonatal Intensive Care Unit
Cincinnati, Ohio, United States, 45267
Cincinnati Childrens Hospital Medical Center Neonatal Intensive Care Unit
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Procter and Gamble
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01619228     History of Changes
Other Study ID Numbers: NCT01546780
Study First Received: June 4, 2012
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
premature infant
neonate
skin maturation
stratum corneum maturation
ontogeny of neonatal skin maturation
sunflower oil
effect of sunflower oil on premature infant skin maturation
skin acidity
stratum corneum barrier integrity
stratum corneum lipid composition
stratum corneum biomarkers
stratum corneum cytokines
stratum corneum structural proteins

ClinicalTrials.gov processed this record on September 18, 2014