Premature Birth of NewbornNCT01619228
Skin Maturation in Premature Infants
An observational study of Premature Birth of Newborn, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 43 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Birth of Newborn
- How many people
- 107 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 43 weeks
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
- 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
- Parent of an infant enrolled in the study
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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:
- 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
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Childrens Hospital Medical Center Neonatal Intensive Care Unit
Cincinnati, Ohio, 45229
University Hospital Neonatal Intensive Care Unit
Cincinnati, Ohio, 45267
About this study
Official title: Ontogeny of Skin Barrier Maturation in Premature 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.
Read the 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 surface acidity in premature infants will be related to an altered lipid composition which will change as the skin acidifies.
Full thickness skin samples will be collected from premature and full term infants during the time of medically necessary surgical procedures for genomic/transcriptomics analyses. The gene profiles will be compared to the corresponding biomarker profiles to determine the relationship between genes and gene expression products, i.e., biomarkers. The genomic/transcriptomics, biomarker, instrumental and clinical assessments will be examined for relationships and compared between premature and full term cohorts.
- 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
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until six months after discharge
Secondary outcomes (1)
Skin Surface Acidity
Skin surface acidity in premature infants will be compared to the lipid composition. The skin surface acidity and the lipid composition will be compared over time for premature and full term infants. 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 very low birth weight infants, skin acidity varies with gestational age and is higher for a longer time compared with full term infants.
Measured: Until six months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Marty O Visscher, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619228
- Sponsor's protocol ID
- CCHMC IRB 2011-1840
- Status last verified
- May 2018
- First submitted
- 4 Jun 2012
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ontogeny of Skin Barrier Maturation in Premature Infants
- ClinicalTrials.gov ID
- NCT01619228
- Acronym / sponsor ID
- CCHMC IRB 2011-1840
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Apr 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 surface acidity in premature infants will be related to an altered lipid composition which will change as the skin acidifies.
Full thickness skin samples will be collected from premature and full term infants during the time of medically necessary surgical procedures for genomic/transcriptomics analyses. The gene profiles will be compared to the corresponding biomarker profiles to determine the relationship between genes and gene expression products, i.e., biomarkers. The genomic/transcriptomics, biomarker, instrumental and clinical assessments will be examined for relationships and compared between premature and full term cohorts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 24 to 43 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
1 secondary outcome
Skin Surface Acidity
Time frame: Until six months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Premature Birth of Newborn
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Prematurity, Feeding Behaviors
Not yet recruitingObservational study
Effect of Antenatal Dexamethasone on Postnatal Adrenal Hormones in Preterm Neonates
Preterm Birth Infants
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marty O Visscher, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth of Newborn, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.