Effect of Twice Daily Application of Coconut Oil in Reducing Water Loss From Skin of Premature Babies in First Week of Life (TEWL)

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ClinicalTrials.gov Identifier: NCT01758068

Recruitment Status : Completed

First Posted : December 31, 2012

Last Update Posted : December 31, 2012

Sponsor:

Collaborator:

All India Institute of Medical Sciences, New Delhi

Information provided by (Responsible Party):

Sushma Nangia, M.D., Lady Hardinge Medical College

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Trans Epidermal Water Loss	Procedure: Coconut Oil Application	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	74 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail
Study Start Date :	November 2005
Actual Primary Completion Date :	September 2006
Actual Study Completion Date :	December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Arm

Intervention/treatment

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.

Outcome Measures

Primary Outcome Measures :

Trans Epidermal Water Loss(TEWL) [ Time Frame: first 7 days of life ]
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 ]
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 ]
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 ]
The skin swab cultures were sent after 1week of life to assess for skin colonization

Eligibility Criteria

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Ages Eligible for Study:	up to 7 Days (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758068

Sponsors and Collaborators

Lady Hardinge Medical College

All India Institute of Medical Sciences, New Delhi

Investigators


Principal Investigator:	Sushma Nangia, MD, DM	All India Institute of Medical Sciences, New Delhi

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nangia S, Paul VK, Deorari AK, Sreenivas V, Agarwal R, Chawla D. Topical Oil Application and Trans-Epidermal Water Loss in Preterm Very Low Birth Weight Infants-A Randomized Trial. J Trop Pediatr. 2015 Dec;61(6):414-20. doi: 10.1093/tropej/fmv049. Epub 2015 Sep 3.


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
First Posted:	December 31, 2012 Key Record Dates
Last Update Posted:	December 31, 2012
Last Verified:	December 2012

Keywords provided by Sushma Nangia, M.D., Lady Hardinge Medical College:


Preterms Coconut Oil application Trans epidermal water loss Weight gain

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