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

NCT ID: NCT01758068

Last Updated: 2012-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Trans Epidermal Water Loss

Keywords

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Preterms Coconut Oil application Trans epidermal water loss Weight gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)..

Group Type EXPERIMENTAL

Coconut Oil Application

Intervention Type PROCEDURE

Coconut oil - 4 ml

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Coconut Oil Application

Coconut oil - 4 ml

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

12 Hours

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role collaborator

Lady Hardinge Medical College

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sushma Nangia, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sushma Nangia, MD, DM

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

References

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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.

Reference Type DERIVED
PMID: 26338490 (View on PubMed)

Other Identifiers

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AIIMS/06/TEWL

Identifier Type: -

Identifier Source: org_study_id