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:

* Participant (i.e. the neonate) must have a parent or sibling with a history of doctor-diagnosed atopy (i.e. at least one of: eczema, asthma, hayfever)
* Mother aged ≥18 years of age at enrolment
* Baby \<36 weeks gestation at screening
* Informed consent from the mother on behalf of the participant
* Mother has the ability to understand English
* Live in a hard water area (\>250 mg/L Calcium Carbonate)
* Consent of landlord for installation on water softener (if appropriate)
* Occupy a property appropriate for installation of a water softener

Exclusion Criteria:

* Preterm birth (defined as birth prior to 37 weeks gestation)
* Significant inflammatory skin disease at birth not including seborrheic dermatitis ("cradle cap")
* Sibling (including twin) previously randomised to this trial. If multiple birth, the first child will be randomised into the trial.
* The child is to be fostered/adopted
* Any immunodeficiency disorder or severe genetic skin disorder
* Child has any other serious health issue which, at parent or investigator discretion, would make it difficult for the family to take part in the trial.
* Planned stays away from home for a continuous period of more than 2 weeks or a total of 1 month out of the 6 month follow up period
* Water softening or filtration device already installed
* Concurrent enrolment in any other skin-related intervention study
* Other medical condition that in the opinion of the CI could interfere with the conduct of the trial
B: Inclusion Criteria:

* Born between 34 weeks + 0 days and 36 weeks + 6 days (late preterms),
* With a body weight of over 2000g,
* Spontaneous breathing,
* Preterms with stable physiological parameters

Exclusion Criteria:

* Receiving mechanical ventilation support,
* HIV, Hepatitis B mother baby,
* Preterms bathed before the intervention,
* Surgical procedure and incision in any region,
* Preterms with central catheters,
* Preterms with systemic infection,
* Preterms using sedative and / or muscle relaxants,
* Preterms with congenital, chromosomal abnormalities
C: 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
D: 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

Answer: C