Topical Emollient Therapy

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

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-01-31

Brief Summary

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Almost all (99%) of the neonatal deaths occur in lower and middle income countries. Most of these deaths are attributable to prematurity and infection. With the increasing rate of premature births in some settings, the mortality rate of over 50% among preterm babies in some of the developing countries require inexpensive hospital-based strategies to prevent fatal infections in newborns of these countries. As most of the deaths in preterm neonates are attributable to their vulnerability of infection, a potential low cost intervention like topical emollient therapy can be effectively directed to reduce infection related mortality and morbidity in the developing countries. Topical emollient therapy reduces the rate of infection by enhancing the skin barrier function, thus reducing trans-epidermal water loss consequently conserving heat and energy to promote growth.

The broad goal of the study is to improve the survival rate of hospitalized preterm neonates in the developing countries by decreasing the incidence of infection using low-cost interventions.

HYPOTHESIS:

It is hypothesized that topical emollient therapy with coconut oil twice a day till 28th day of life in hospitalized preterm neonates reduces the incidence proportion of hospital acquired infection by 40% 15 as compared to routine skin care. For the secondary objective it is hypothesized that the weight gain in the neonates receiving prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day18 more as compared to the weight gain in the routine skin care group.

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Detailed Description

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Research question:

1. The primary research question to be addressed via this study is whether the prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, effective in reducing the incidence proportion of hospital acquired infection among preterm neonates by 40% as compared to the routine skin care.
2. The secondary research question is whether the weight gain in the neonates receiving prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day more as compared to the weight gain in the routine skin care group.

Objectives: This study has the following primary objectives:

1. To evaluate the effectiveness of topical emollient in preventing hospital acquired infection in preterm neonates.

The secondary objective is:
2. To compare the weight gain among the two groups of neonates.

Conditions

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Blood Stream Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Topical Emollient

Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life

Group Type EXPERIMENTAL

Topical Emollient

Intervention Type OTHER

Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life

Routine Skin Care

Neonates in this group will receive routine skin care as per unit protocol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Topical Emollient

Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Any preterm neonates (\>26 weeks and \< 37 weeks of gestation by maternal dates)
2. Birth weight of at least 750 gm
3. Age ≤72 hours of life
4. Baseline blood cultures obtained
5. Expected survival \> 48 hours (based on the clinical judgment by the physicians)

Exclusion Criteria

1. Neonate with severe RDS on admission as declared by the consulting Physician on the basis of radiologic findings.
2. Neonate within first 24 hours of critical care
3. Life threatening congenital anomalies
4. Congenital skin anomalies
5. Hydrops Fetalis
6. Congenital infection of the skin
7. History of any previous treatment with the ointment
8. Newborns admitted for major surgical procedure with expected high rates of infectious complications.
9. Newborns with positive baseline blood cultures

Minimum Eligible Age

5 Minutes

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No