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Completed

NCT Number: NCT01758068

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

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.

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Key information

Conditions

Trans Epidermal Water Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

12 hour–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Coconut Oil Application

Procedure

Coconut oil - 4 ml

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Lady Hardinge Medical College

Other Gov

Collaborators

  • All India Institute of Medical Sciences

Registry information

Official study title

Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail

Acronym: TEWL

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 31, 2012
Registry last updated
Dec 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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