Effect of Twice Daily Application of Coconut Oil in Reducing Water Loss From Skin of Premature Babies in First Week of Life (TEWL)
This study has been completed.
Sponsor:
Lady Hardinge Medical College
Collaborator:
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
Sushma Nangia, M.D., Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01758068
First received: December 23, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Trans Epidermal Water Loss |
Procedure: Coconut Oil Application |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail |
Resource links provided by NLM:
Further study details as provided by Lady Hardinge Medical College:
Primary Outcome Measures:
- Trans Epidermal Water Loss(TEWL) [ Time Frame: first 7 days of life ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Weight [ Time Frame: first 7 days of life and 40 weeks postmenstrual age ] [ Designated as safety issue: No ]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.
- Skin condition Score [ Time Frame: at day 7 of life ] [ Designated as safety issue: No ]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.
- Skin colonization pattern [ Time Frame: at day 7 of life ] [ Designated as safety issue: No ]The skin swab cultures were sent after 1week of life to assess for skin colonization
| Enrollment: | 74 |
| Study Start Date: | November 2005 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Coconut Oil Application
The oil (coconut oil) was applied by the trained nurse to the entire body surface of infant except the face two times a day started as early as possible Four ml of coconut oil was applied using both hands of the caregiver in four strokes starting from the level of clavicles over the chest and abdomen till the groin, from the front of thighs, knee, leg and upto the sole, from above the shoulders over the arm and forearm till the palm continuing medially over the forearm and arm till the axilla and the final stroke was used for the back reaching over the back of the thighs till the heel. Just prior to the first application, and thereafter prior to the subsequent applications the TEWL was recorded using the portable closed chamber evaporimeter. The oil application was continued twice daily (every 12 hrs at the same time as the hour of birth e.g. 11 am and 11pm) till the completion of the seventh day (168 hrs of life)..
|
Procedure: Coconut Oil Application
Coconut oil - 4 ml
|
|
No Intervention: No Oil Application
Babies in this group were not subjected to oil application. TEWL measurement was recorded every 12 hrs for the first week of life, at the same time as the hour of birth.
|
Eligibility| Ages Eligible for Study: | up to 7 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
All preterm babies born at the study center with birth weight < 1500g were eligible for inclusion in the study.
Exclusion Criteria:
- Babies with birth weight less than 750 gms at birth
- Babies with major congenital malformations.
- Babies with severe asphyxia, hydrops and shock.
- Babies with congenital diseases of skin associated with skin breach or denudation of skin precluding oil application
- 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)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sushma Nangia, M.D., Professor, Lady Hardinge Medical College |
| ClinicalTrials.gov Identifier: | NCT01758068 History of Changes |
| Other Study ID Numbers: | AIIMS/06/TEWL |
| Study First Received: | December 23, 2012 |
| Last Updated: | December 23, 2012 |
| Health Authority: | India: Indian Council of Medical Research |
Keywords provided by Lady Hardinge Medical College:
|
Preterms Coconut Oil application Trans epidermal water loss Weight gain |
ClinicalTrials.gov processed this record on May 19, 2013