Newborn Infection Control and Care Initiative for Health Facilities to Accelerate Reduction of Newborn Mortality

NCT02271737 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1938

Last updated 2015-06-12

No results posted yet for this study

Summary

Newborn mortality continues to be unacceptably high in Cambodia, despite reductions in maternal and under five year old mortality. Evidence exists that a large proportion of newborn mortality globally and in Cambodia is attributable to infections and sepsis. The study proposes a package intervention to address infection control in the perinatal period in facilities and to improve the timeliness of referral of newborns with suspected infections to appropriate health facilities for treatment through upgrading of hygiene practices in facilities and linking of community based volunteers with health facilities and families in the community setting.

By delivering a coordinated intervention that combines improved education for health center midwives, village health care workers, and mothers of newborns, along with improved care coordination with increase in number of interactions (points of contact) between mothers and health care personnel, the investigators will see improved knowledge of newborn danger signs among mothers and health care workers, more rapid case detection of significant newborn illnesses, and more rapid and appropriate referral of ill newborns.

The investigators also hypothesize that the common causes of newborn sepsis in Cambodia are different from those reported in Western cultures, and that Staphylococcus aureus will be a common pathogen as described in neighboring Laos. The investigators will evaluate the causes of newborn sepsis in the subset of infants referred to Takeo Provincial Hospital.

Conditions

  • Neonatal Infection

Interventions

BEHAVIORAL

Training HC/VHSG, Health Education, and Supportive Supervision

1\. Improve infection control Practice at health centers; 2) improve knowledge on newborn danger signs among HC staff, VHSG, and the mothers; 3) improve care coordination between community and health facilities, e.g. improve referral of sick newborns

Sponsors & Collaborators

  • Tulane University School of Public Health and Tropical Medicine

    collaborator OTHER
  • United States Agency for International Development (USAID)

    collaborator FED
  • National Institute of Public Health, Cambodia

    lead OTHER_GOV

Principal Investigators

  • Oberhelman Richard Alfred, MD · Tulane University

  • Alessandra N Bazzano, PhD · Tulane University

  • Chivorn Var, MD, MPH · National Institute of Public Heath, Cambodia

  • Navapol IvEk, MD, MPH · National Institute of Public Health, Cambodia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-12-31
Completion
2017-06-30

Countries

  • Cambodia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02271737 on ClinicalTrials.gov