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

NCT02271737 | Unknown

• 1 other identifier: 15
• Study Type: interventional
• Target: 1,938
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Infection

Keywords

Newborn; infection; community health

Outcome Measures

Primary Outcomes (6)

• % of mothers who know at last 3 danger signs

  2 years

• % of VHSG who know 6 danger signs

  2 years

• % of families who seek care from an appropriate facility

  2 years

• Time between onset of suspected danger signs and referral to appropriate facility

  2 years

• Improved hygiene behavior by family

  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.

  2 years

• Improved infection control behavior among HC staff

  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

  2 years

Secondary Outcomes (8)

• % of newborns visited at least once by VHSG on or before day 7 of life

  2 years

• % of newborns visited at least twice by VHSG on or before day 7 of life

  2 years

• % of VHSG who can deliver hygiene messages

  2 years

• % of mothers who received messages on hygiene from HC staff

  2 years

• % of mothers who received messages on hygiene from VHSG

  2 years

Other Outcomes (3)

• All causes newborn mortality

  2 years

• Age and cause specific mortality rates

  2 years

• Incidence rate of newborns with the following danger signs: convulsion, respiratory distress, fever or hypothermia, lethargy, and skin pustules

  2 years

Study Arms (2)

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

No Intervention

NO INTERVENTION

We do not make any interventions.

Interventions

Training HC/VHSG, Health Education, and Supportive Supervision BEHAVIORAL

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Public Health, Cambodia: lead
• Tulane University School of Public Health and Tropical Medicine: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Selected Health Centers and Villages Under the Health Centers

Takeo, Takeo Province, Cambodia

Location

Related Publications (3)

• National Maternal Child Health Center, Verbal Autopsy Study Svay Rieng, Ministry of Health, Editor 2009

  BACKGROUND

• Lawn JE, Wilczynska-Ketende K, Cousens SN. Estimating the causes of 4 million neonatal deaths in the year 2000. Int J Epidemiol. 2006 Jun;35(3):706-18. doi: 10.1093/ije/dyl043. Epub 2006 Mar 23.

  PMID: 16556647 RESULT

• Var C, Bazzano AN, Srivastav SK, Welty JC, Ek NI, Oberhelman RA. Newborn Infection Control and Care Initiative for health facilities to accelerate reduction of newborn mortality (NICCI): study protocol for a randomized controlled trial. Trials. 2015 Jun 5;16:257. doi: 10.1186/s13063-015-0771-5.

  PMID: 26044715 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Oberhelman Richard Alfred, MD

  Tulane University

  STUDY CHAIR

• Alessandra N Bazzano, PhD

  Tulane University

  STUDY CHAIR

• Chivorn Var, MD, MPH

  National Institute of Public Heath, Cambodia

  PRINCIPAL INVESTIGATOR

• Navapol IvEk, MD, MPH

  National Institute of Public Health, Cambodia

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2014
• First Posted: October 22, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 12, 2015

Record last verified: 2015-06

Locations

CA (1)