Topical Emollient Therapy

NCT01396642 | Completed DMC

• 1 other identifier: 1258-CHS/ERC-09
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Blood Stream Infection

Keywords

Topical Emollient Therapy; Emollient; Preterm; Hospital Acquired Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Weight Gain

  28th Day of Life

Study Arms (2)

Topical Emollient

EXPERIMENTAL

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

Other: Topical Emollient

Routine Skin Care

NO INTERVENTION

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

Interventions

Topical Emollient OTHER

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

Topical Emollient

Eligibility Criteria

• Age: 5 Minutes - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (2)

The Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

The Aga Khan University

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 25637007 DERIVED

MeSH Terms

Conditions

Premature Birth; Cross Infection

Interventions

Emollients

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Zulfiqar ZB Bhutta, MBBS, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Rehana A Salam, MSc

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 19, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

PA (2)