Topical Emollient Therapy

Blood Stream Infection Clinical Trial

Official title:

Effect of Topical Emollient Therapy on Clinical Outcomes in Preterm Neonates - A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396642
• Other study ID #: 1258-CHS/ERC-09
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: April 5, 2015
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2015
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: The Aga Khan University
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 72 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Stream Infection

Intervention

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

Locations

Country	Name	City	State
Pakistan	The Aga Khan University	Karachi	Sindh
Pakistan	The Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Acquired Blood Stream Infection	Hospital Acquired Infection is defined as a blood culture positive for any organism in a neonate with baseline negative cultures on admission.	28 days of life	No
Secondary	Weight Gain		28th Day of Life	No