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Trial record 26 of 3456 for:    Facility

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

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ClinicalTrials.gov Identifier: NCT02271737
Recruitment Status : Unknown
Verified June 2015 by Var Chivorn, National Institute of Public Health, Cambodia.
Recruitment status was:  Enrolling by invitation
First Posted : October 22, 2014
Last Update Posted : June 12, 2015
Sponsor:
Collaborators:
Tulane University School of Public Health and Tropical Medicine
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Var Chivorn, National Institute of Public Health, Cambodia

Brief 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.


Condition or disease Intervention/treatment Phase
Neonatal Infection Behavioral: Training HC/VHSG, Health Education, and Supportive Supervision Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1938 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Newborn Infection Control and Care Initiative for Health Facilities to Accelerate Reduction of Newborn Mortality
Study Start Date : February 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Improve infection control in health centers; improve home hygiene; improve newborn danger signs recognition by the HC staff, VHSG, and mothers; and improve care coordination between community and health facilities. The above improvements will be through the training of health center staff and VHSG; HC staff and VHSG provide health education to mothers at the health centers and at home respectively; and provide supportive supervision to both HC and VHSG. VHSG will conduct three home visits to the mothers/newborns on the first 24 hours, the 3rd day, and the 7th day after delivery.
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

No Intervention: No Intervention
We do not make any interventions.



Primary Outcome Measures :
  1. % of mothers who know at last 3 danger signs [ Time Frame: 2 years ]
  2. % of VHSG who know 6 danger signs [ Time Frame: 2 years ]
  3. % of families who seek care from an appropriate facility [ Time Frame: 2 years ]
  4. Time between onset of suspected danger signs and referral to appropriate facility [ Time Frame: 2 years ]
  5. Improved hygiene behavior by family [ Time Frame: 2 years ]
    It is a composite score of: 1) % of mothers/caretakers interviewed said they wash hand after going to toilet; 2) % of mothers/caretakers interviewed said that they wash hand before touching newborn; 3) % of mothers/caretakers interviewed said that they wash hand before eating; and 4) % of mothers/caretakers interviewed said that they wash hand after cleaning baby's bottom.

  6. Improved infection control behavior among HC staff [ Time Frame: 2 years ]
    A composite score from: % of HC staff reported that they washed hands: 1) before patient contact (when they examine mother and newborn); 2) Before and after aseptic procedure; 3) After expose to blood/body fluids; 4) after patient contact (after removing gloves); and 5) after touching patient surroundings


Secondary Outcome Measures :
  1. % of newborns visited at least once by VHSG on or before day 7 of life [ Time Frame: 2 years ]
  2. % of newborns visited at least twice by VHSG on or before day 7 of life [ Time Frame: 2 years ]
  3. % of VHSG who can deliver hygiene messages [ Time Frame: 2 years ]
  4. % of mothers who received messages on hygiene from HC staff [ Time Frame: 2 years ]
  5. % of mothers who received messages on hygiene from VHSG [ Time Frame: 2 years ]
  6. % of mothers who received messages on care seeking from VHSG [ Time Frame: 2 years ]
  7. % of HC staff who know 6 danger signs [ Time Frame: 2 years ]
  8. % of HC staff who recall hygiene messages [ Time Frame: 2 years ]

Other Outcome Measures:
  1. All causes newborn mortality [ Time Frame: 2 years ]
  2. Age and cause specific mortality rates [ Time Frame: 2 years ]
  3. Incidence rate of newborns with the following danger signs: convulsion, respiratory distress, fever or hypothermia, lethargy, and skin pustules [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Health Centers: historically, a health center which providing services for more than 20 births per month
  • Individuals: women in the last trimester of pregnancy with any ethnicity, age is equal or older than 18 years, and pregnancy results in a live birth.

Exclusion Criteria:

  • Birth of baby with known congenital malformation
  • Inability to obtain informed consent or adhere to protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271737


Locations
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Cambodia
Selected Health Centers and Villages Under the Health Centers
Takeo, Takeo Province, Cambodia
Sponsors and Collaborators
National Institute of Public Health, Cambodia
Tulane University School of Public Health and Tropical Medicine
United States Agency for International Development (USAID)
Investigators
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Study Chair: Oberhelman Richard Alfred, MD Tulane University
Study Chair: Alessandra N Bazzano, PhD Tulane University
Principal Investigator: Chivorn Var, MD, MPH National Institute of Public Heath, Cambodia
Study Director: Navapol IvEk, MD, MPH National Institute of Public Health, Cambodia

Publications of Results:
Other Publications:
National Maternal Child Health Center, Verbal Autopsy Study Svay Rieng, Ministry of Health, Editor 2009

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Var Chivorn, Principle Investigator, National Institute of Public Health, Cambodia
ClinicalTrials.gov Identifier: NCT02271737     History of Changes
Other Study ID Numbers: 15
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Keywords provided by Var Chivorn, National Institute of Public Health, Cambodia:
Newborn
infection
community health
Additional relevant MeSH terms:
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Infection
Communicable Diseases