Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Topical Emollient Therapy on Clinical Outcomes in Preterm Neonates - A Clinical Trial
Brief Summary: Almost all (99%) of the neonatal deaths occur in lower and middle income countries. Most of these deaths are attributable to prematurity and infection. With the increasing rate of premature births in some settings, the mortality rate of over 50% among preterm babies in some of the developing countries require inexpensive hospital-based strategies to prevent fatal infections in newborns of these countries. As most of the deaths in preterm neonates are attributable to their vulnerability of infection, a potential low cost intervention like topical emollient therapy can be effectively directed to reduce infection related mortality and morbidity in the developing countries. Topical emollient therapy reduces the rate of infection by enhancing the skin barrier function, thus reducing trans-epidermal water loss consequently conserving heat and energy to promote growth.

The broad goal of the study is to improve the survival rate of hospitalized preterm neonates in the developing countries by decreasing the incidence of infection using low-cost interventions.

HYPOTHESIS:

It is hypothesized that topical emollient therapy with coconut oil twice a day till 28th day of life in hospitalized preterm neonates reduces the incidence proportion of hospital acquired infection by 40% 15 as compared to routine skin care. For the secondary objective it is hypothesized that the weight gain in the neonates receiving prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day18 more as compared to the weight gain in the routine skin care group.


Options:
A: Inclusion Criteria:

* Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study
* Child specific written informed consent, if over 7 years of age
* Subjects with a general good and stable health condition
* Subjects with clinically stable medical conditions
* Accept to abstain from sunbathing and solarium during the study
* Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs
* TEWL \> 12 g/m2/h on the left mid volar forearm

Exclusion Criteria:

* Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars
* Suffering from porphyria
* Suffering from severe photodermatoses according to the judgment of the investigator
* Clinically significant, possibly unstable medical conditions such as metastatic tumor
* Currently having other malignant or benign tumors of the skin in the investigational area
* Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion
* Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol
* Use of (medical) oil-containing bath additives or other oil-containing cleansers
* Current topical or systemic treatment affecting the skin, e.g. diuretics
* Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before inclusion
* Systemic immunosuppressive or immunomodulatory therapy
* Topical retinoids applied during the 6 weeks before inclusion
* Topical application of immunosuppressive treatment during the 6 weeks before inclusion
* Therapeutic UV-Radiation during the 6 weeks before inclusion
* Increased UV-exposure during the 6 weeks before inclusion
B: The study enrolls Mother-child pairs in two steps; first mother, thereafter her new-born baby.

Inclusion Criteria:

1. Ante-natal inclusion, step 1: All mothers to-be at 18 weeks ultrasound investigation with sufficient language skills (Norwegian or Swedish), gestational age: at least 16-22 weeks.

1. Exclusion: Plans to move further than reasonable travel distance from any of the participating hospitals within the first year of the offspring's life.

1. Inclusion of the child, step 2: Live-born babies of gestational age 35.0 weeks or more (including multiple pregnancies), maternal/parental willingness to participate in the study

Exclusion Criteria:

Exclusion criteria child: 1) severe neonatal cardiac, pulmonary, neurologic, dermatologic disease or other disease that may influence the outcomes 2), plans to move further than reasonable travel distance away from any of the participating hospitals within the first nine months of life.

3) Non-willingness to participate, 4) More than two foetuses
C: Inclusion Criteria:

* Parent can provide electronic signed and dated informed consent form.
* Parent is willing and able to comply with all study procedures for the duration of the study.
* Parent is a primary caretaker of an infant 0 to 2 months of age.
* Parent is 18 years of age or older at time of consent.
* Parent can speak, read, and write in English or Spanish.
* Parent has a valid e-mail address or phone that can receive text messages
* Parent has reliable access to the internet.
* Infant is a patient of a participating Meta-LARC clinic site at the time of consent.

Exclusion Criteria:

* Infant was born at less than 25 weeks gestational age.
* Infant has established eczema as diagnosed by the primary healthcare provider at clinic site of enrollment per parent report.
* Infant has known adverse reaction to petrolatum-based emollients.
* Infant has an immunodeficiency genetic syndrome such as Wiskott-Aldrich Syndrome or Severe Combined Immunodeficiency Syndrome.
* Infant has extremely low birth weight (less than 1000g or 2.2 lbs at birth).
* Infant has a sibling enrolled in the study.
* Parent is unwilling or unable to comply with study procedures.
D: Inclusion Criteria:

1. Any preterm neonates (\>26 weeks and \< 37 weeks of gestation by maternal dates)
2. Birth weight of at least 750 gm
3. Age ≤72 hours of life
4. Baseline blood cultures obtained
5. Expected survival \> 48 hours (based on the clinical judgment by the physicians)

Exclusion Criteria:

1. Neonate with severe RDS on admission as declared by the consulting Physician on the basis of radiologic findings.
2. Neonate within first 24 hours of critical care
3. Life threatening congenital anomalies
4. Congenital skin anomalies
5. Hydrops Fetalis
6. Congenital infection of the skin
7. History of any previous treatment with the ointment
8. Newborns admitted for major surgical procedure with expected high rates of infectious complications.
9. Newborns with positive baseline blood cultures

Answer: D