Topical Emollient Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Stream Infection
• Intervention / Treatment: Other: Topical Emollient

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • The Aga Khan University
    • Karachi, Sindh, Pakistan
      • The Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 minutes to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Emollient; Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life	Other: Topical Emollient; Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life
No Intervention: Routine Skin Care; Neonates in this group will receive routine skin care as per unit protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight Gain	28th Day of Life

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: Zulfiqar ZB Bhutta, MBBS, PhD, The Aga Khan University; Principal Investigator: Rehana A Salam, MSc, The Aga Khan University

Publications and helpful links

General Publications

• Salam RA, Darmstadt GL, Bhutta ZA. Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F210-5. doi: 10.1136/archdischild-2014-307157. Epub 2015 Jan 30.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 5, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Preterm; Emollient; Topical Emollient Therapy; Hospital Acquired Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Dermatologic Agents; Emollients
• Other Study ID Numbers: 1258-CHS/ERC-09