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:

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

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:

MedlinePlus related topics: Drinking Water

U.S. FDA Resources

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.

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

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Please refer to this study by its ClinicalTrials.gov identifier: 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

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 March 03, 2015

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