Neonatal Bacterial Colonization Study

NCT03896893 | Unknown DMC

• 2 other identifiers: N18/07/0685K43TW010682
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effect of skin antisepsis and/or emollient therapy on bacterial colonization dynamics in very low birth weight, hospitalized infants. Bacterial swabs from 5 body sites will be collected at baseline, day 3, day 8 and day 13 following study arm assignment. Study outcomes include changes in bacterial colony counts, burden of gram-negative and gram-positive pathogens and overall skin score.

Conditions

Neonatal SEPSIS; Prematurity; Very Low Birth Weight Baby; Bloodstream Infection

Outcome Measures

Primary Outcomes (4)

• Change in median bacterial colony counts by body site over time

  baseline, day 3, day 8 and day 13 post enrolment

• Change in Gram negative pathogen burden by body site over time

  baseline, day 3, day 8 and day 13 post enrolment

• Change in Gram positive pathogen burden by body site over time

  baseline, day 3, day 8 and day 13 post enrolment

• Change in median skin condition score over time (Grading scale adapted by Darmstadt from Lane at al)

  Darmstadt skin score uses a 9-point scale (calculated as the sum of points for each of 3 items: skin eythema, dryness and breakdown, with a minimum score of 1 and maximum score of 3, representing worst possible skin condition for each sub-scale, total sum of points is a minimum score of 3 and maximum score of 9 for worst possible skin condition)

  Daily from enrolment to day 13 post enrolment

Secondary Outcomes (2)

• Incidence of laboratory-confirmed sepsis

  up until day 28 of life

• Incidence of clinically-suspected sepsis

  up until day 28 of life

Study Arms (4)

Standard of Care

NO INTERVENTION

Routine bathing and skin care as per hospital practice

1% chlorhexidine gluconate (CHG)

EXPERIMENTAL

1% aqueous CHG applied from the neck down with cotton swabs daily on weekdays (total of 8 days CHG application)

Other: Skin antisepsis

Emollient therapy

EXPERIMENTAL

Aquaphor skin cream applied from the neck down daily on weekdays (total of 8 days emollient application)

Other: Emollient

1% CHG plus emollient therapy

EXPERIMENTAL

1% aqueous CHG applied from the neck down with cotton swabs daily on weekdays followed immediately by Aquaphor skin cream (total of 8 days CHG application plus emollient application)

Other: Skin antisepsis; Other: Emollient

Interventions

Skin antisepsis OTHER

1% aqueous chlorhexidine gluconate

1% CHG plus emollient therapy; 1% chlorhexidine gluconate (CHG)

Emollient OTHER

Aquaphor skin cream

1% CHG plus emollient therapy; Emollient therapy

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birth weight ≥1000g and ≤ 1500g (equivalent to gestational age 28 - 32 weeks)
• Day 1 or 2 or 3 of life
• Anticipated length of hospital stay \> 7 days.

You may not qualify if:

• Birth weight \<1000g or \>1500g
• Mother not present, unable or unwilling to provide consent for enrolment
• Any skin condition or congenital defect that could potentially result in enhanced CHG absorption (skin blistering/bullae, congenital anomalies e.g. gastroschisis, spina bifida)
• Anticipated length of hospital stay \< 7 days.

Sponsors & Collaborators

• University of Stellenbosch: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Tygerberg Hospital

Cape Town, Western Cape, 7503, South Africa

RECRUITING

Related Publications (1)

• Dramowski A, Pillay S, Bekker A, Abrahams I, Cotton MF, Coffin SE, Whitelaw AC. Impact of 1% chlorhexidine gluconate bathing and emollient application on bacterial pathogen colonization dynamics in hospitalized preterm neonates - A pilot clinical trial. EClinicalMedicine. 2021 Jun 18;37:100946. doi: 10.1016/j.eclinm.2021.100946. eCollection 2021 Jul.

  PMID: 34195575 DERIVED

MeSH Terms

Conditions

Neonatal Sepsis; Premature Birth; Sepsis

Interventions

Emollients

Condition Hierarchy (Ancestors)

Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Angela Dramowski, MD, PhD

CONTACT

+27219389506; dramowski@sun.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Enrolled babies will be sequentially recruited to one of 4 study arms (see below).

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 1, 2019
• Study Start: March 4, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Anticipated availability from first quarter 2020

Locations

ZA (1)