CompletedNot Applicable

Skin Maturation in Premature Infants

United States107 participantsStarted 2012-04

Plain-language 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.

Who can participate

Age range

24 Weeks – 43 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Premature infants of gestational ages 24 to 36.9 weeks
. Full term infants ≥ 37 weeks gestational age

Exclusion criteria

. 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.
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Until six months after discharge

Trial details

NCT IDNCT01619228

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-03

View on ClinicalTrials.gov More Premature Birth of Newborn trials