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

Not Applicable

Completed

• Conditions: Trans Epidermal Water Loss (TEWL)

• Registration Number: NCT01364948
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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. Oil application on the skin can act as a non permeable barrier and can help in reducing water loss from the skin. Edible coconut oil, often used for traditional massage of babies by Indian communities, is culturally acceptable and Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-12
• Study Start: 2006-01
• Primary Completion: 2006-11
• Study Completion: 2006-12
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-01
• Last Update Submitted: 2011-06-01
• Study First Posted: 2011-06-03
• Last Update Posted: 2011-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

All preterm babies born at the study center with birth weight < 1500gms 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Trans Epidermal Water Loss(TEWL)	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 during the first week of life (168 hrs of life)

Secondary Outcome Measures

Name	Time	Method
Weight	Weight 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	Skin condition Score 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	Skin colonization pattern at day 7 of life	The skin swab cultures were sent after 1week of life to assess for skin colonization

Trial Locations

Locations (1)

All India Institute Of Medical Sciences; 🇮🇳 New Delhi, Delhi, India