Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04325451
Eligibility Criteria:
Inclusion Criteria:
1. A healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment \& less than 120 hours prior to enrollment
2. Term and near term newborns born between 34+0 and 42+0 weeks gestational age
3. Mothers must be aged \>18 years
4. Parents' ability to complete questionnaire(s) at defined times throughout study duration
5. Parents or legal guardian provide informed written consent
Exclusion Criteria:
1. Preterm birth prior to 34+0 weeks gestation
2. Less than 12 hours out of the incubator
3. Neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days
4. Neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult
5. Neonate has been administered oral or parenteral antibiotics from birth until study enrollment
6. Neonate has a serious health issue which, at parent or investigator discretion, would make it difficult for the neonate or parents to take part in the trial
7. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Hours
Maximum Age:
120 Hours
Study:
NCT04325451
Study Brief:
Protocol Section:
NCT04325451