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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.
Research question:
Objectives: This study has the following primary objectives:
To evaluate the effectiveness of topical emollient in preventing hospital acquired infection in preterm neonates.
The secondary objective is:
To compare the weight gain among the two groups of neonates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Emollient | Experimental | Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life |
|
| Routine Skin Care | No Intervention | Neonates in this group will receive routine skin care as per unit protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Emollient | Other | Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Acquired Blood Stream Infection | Hospital Acquired Infection is defined as a blood culture positive for any organism in a neonate with baseline negative cultures on admission. | 28 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain | 28th Day of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zulfiqar ZB Bhutta, MBBS, PhD | Aga Khan University | Principal Investigator |
| Rehana A Salam, MSc | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Aga Khan University | Karachi | Sindh | 74800 | Pakistan | ||
| The Aga Khan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25637007 | Derived | Salam RA, Darmstadt GL, Bhutta ZA. Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F210-5. doi: 10.1136/archdischild-2014-307157. Epub 2015 Jan 30. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004643 | Emollients |
| ID | Term |
|---|---|
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Karachi |
| Sindh |
| Pakistan |
| D000091642 | Urogenital Diseases |
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |