Trans Epidermal Water Loss Clinical Trial
— TEWLOfficial title:
Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail
| Verified date | December 2012 |
| Source | Lady Hardinge Medical College |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | India: Indian Council of Medical Research |
| Study type | Interventional |
The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight as water loss from their skin during the first week of life. Many strategies have been utilized by neonatologists to decrease this water loss. Edible coconut oil application on the skin acts as a non permeable barrier and can help in achieving this. Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | December 2006 |
| Est. primary completion date | September 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 7 Days |
| Eligibility |
Inclusion Criteria: All preterm babies born at the study center with birth weight < 1500g were eligible for inclusion in the study. Exclusion Criteria: 1. Babies with birth weight less than 750 gms at birth 2. Babies with major congenital malformations. 3. Babies with severe asphyxia, hydrops and shock. 4. Babies with congenital diseases of skin associated with skin breach or denudation of skin precluding oil application 5. Babies with preexisting skin infection such as multiple furuncles (2 or more skin areas - each limb, head, chest, abdomen and back are the individual areas that will be taken as one area) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Lady Hardinge Medical College | All India Institute of Medical Sciences, New Delhi |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Trans Epidermal Water Loss(TEWL) | TEWL was measured using evaporimeter(Vapometer, Delfin Technologies limited, Kuopio, Finland) at 12 hours of age and thereafter every 12 hours till first 7 days of life | first 7 days of life | No |
| Secondary | Weight | The weight of the neonate was recorded at birth and daily during the first week of life. The weight in grams and weight gain in grams/kilogram/day was measured at 40 weeks post conceptional age. | first 7 days of life and 40 weeks postmenstrual age | No |
| Secondary | Skin condition Score | Skin Condition Score was measured using 'Lane and Drost' Score.This score has 9 scores from 1 to 9, 1 depicting the best skin state and 9 the worst with erythema, blistering & oozing over the entire area. | at day 7 of life | No |
| Secondary | Skin colonization pattern | The skin swab cultures were sent after 1week of life to assess for skin colonization | at day 7 of life | No |