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CTRI Number  CTRI/2024/04/066422 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes
Other (Specify) [Quality improvement study ]  
Study Design  Other 
Public Title of Study   A study to decrease the infection rates in preterm neonates less than 34 weeks in a neonatal intensive care centre (NICU)  
Scientific Title of Study   A Quality Improvement initiative to decrease the hospital-acquired infection in preterm neonates less than 34 weeks in a tertiary neonatal intensive care centre  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Avantika Sood  
Designation  Post graduate student  
Affiliation  Kasturba hospital, Kasturba medical college, Department of Paediatrics  
Address  Department of Paediatrics Kasturba Medical College MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  8105474213  
Fax    
Email  avantikasood9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayashree P  
Designation  Professor  
Affiliation  Kasturba Hospital, Kasturba Medical College, Manipal 
Address  NICU, Department of Pediatrics, Division of neonatology, Kasturba Hospital, Kasturba Medical College, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9886249133  
Fax    
Email  jaya.p@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Shruthi K Bharadwaj  
Designation  Assistant professor  
Affiliation  Kasturba Hospital, Kasturba Medical College, Manipal 
Address  NICU, Department of Neonatology, Kasturba Hospital, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7338321832  
Fax    
Email  shruthi.kb@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 India  
 
Primary Sponsor  
Name  Kasturba Medical College  
Address  Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Avantika Sood  Kasturba Hospital, Manipal/Kasturba Medical College   Department of neonatology, Neonatal intensive care unit, 1st floor, Woman and Child Block
Udupi
KARNATAKA 		 8105474213

avantikasood9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Systematic quality improvement measures, implemented via Plan, Do, Study, Act cycles   Hand hygiene is the most important and single measure that has been shown to reduce infections in ICUs, as per WHO. Other areas to reduce infections are staff awareness and education, use of checklists for procedures and maintenance to reduce CLABSI and VAP, having standard protocols, regular audits and team meetings. The study is planned as follows - 12 weeks of baseline data collection to formulate and analyse the factors that are contributing to the occurrence of infections in the NICU. Followed by 8 weeks of the first Plan, Do, Study, Act cycle (PDSA cycle-1), then 8 weeks of PDSA-2. In the next 12 weeks, the sustenance phase will be implemented, if the interventions are found to be reducing hospital-acquired infections as per the primary outcome. If the target is not met, then another PDSA cycle will be carried out for 8 weeks.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  8.00 Month(s)
Gender  Both 
Details  All preterm neonates born less than or equal to 34 weeks of gestation, (both inborn and outborn) admitted to the NICU will be included in the study.  
 
ExclusionCriteria 
Details  The outborn preterm neonates born less than or equal to 34 weeks of gestation with a documented blood stream infection at the time of admission  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To decrease the bloodstream infections by 30% from the baseline in preterm neonates less than 34 weeks admitted in the NICU   To decrease the bloodstream infections by 30% from the baseline in preterm neonates less than 34 weeks admitted in the NICU  
 
Secondary Outcome  
Outcome  TimePoints 
To decrease the incidence of cumulative sepsis (Blood culture positive & negative), central line associated blood stream infection & ventilator associated pneumonia.   At baseline, at 8 weeks (at end of 1st PDSA cycle), at 16 weeks (at end of 2nd PDSA cycle) & at 28 weeks (at end of sustenance phase)  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   1 in 10 new borns will be born before the completion of 37 weeks of gestation (premature birth). These babies are at a higher risk for morbidity and mortality due to various causes. Infection and sepsis in preterm infants remain the most significant clinical problem that represents a substantial burden on the parents, caregivers, and the healthcare system and is an important cause of mortality. Many factors predispose premature infants for having the greatest risk of developing and succumbing to infection as compared to all other age groups across the age spectrum. The immune system of preterm infants exhibits distinct, rather than deficient, functions compared to more mature and older humans and the immune function in preterm infants contributes to infection risk. Hand hygiene is the most important and single measure that has been shown to reduce infections in intensive care units, as per WHO. Other most common areas to reduce infections in NICU are staff awareness and education, use of checklists for procedures and maintenance to reduce CLABSI and VAP, having standard protocols, regular audits and team meetings. Although much progress in the treatment of infants born preterm has been made, the incidence of infection and sepsis is still high. In spite of all the known standard prevention and treatment methods, the implementation in different NICUs differs leading to increased infections in preterm neonates. The application of systematic quality improvement methods has the potential to reduce various forms of preventable neonatal morbidity and mortality through reliable and consistent application of existing high-level evidence without depending on new medications, technology, or innovations to be developed. This QI study is being conducted to decrease bloodstream infections in neonates <34 weeks of gestation and the cumulative rate of sepsis. Written consent will be taken from the mother/gaurdian of eligible preterm neonates. An interdisciplinary quality improvement team will be formed including neonatologists, pediatricians, postgraduate students, in-charge nurses, clinical nurse managers, clinical nurse educator, respiratory therapy supervisor, infection control nurses, and group D workers. Point of Care in Quality Improvement (POCQI) approach, including Plan, Do, Study Act cycles will be used to conduct the study. In the first 6week period, the old “bundles” and pre-existing practices regarding hand hygiene, regular glove usage, and checklists for invasive procedures will be retained and applied as is. Outcome data will be standardized to reflect the incidence of blood culture positivity per 1000 patient days, infections per 1000 central venous catheter days, catheter-related complications, rates of ventilator-associated pneumonia, meningitis, NEC. Process indicators, such as compliance to glove usage, compliance to hand hygiene and checklists during invasive procedures, will be checked by using weekly audits. The factors that may be contributing to the incidence of hospital-acquired infection will be analyzed. Fishbone analysis, five whys and the Pareto principle will be used in analyzing the barriers. The NICU interdisciplinary QI team will meet twice monthly to develop strategies for reducing healthcare infections in NICU. On the basis of team consensus, current practice will be evaluated and a detailed plan for improving practices will be developed as per the Point of Care in Quality Improvement (POCQI) approach, including Plan, Do, Study Act cycles. An intervention period, in the form of the PDSA cycle will take place, where educational modules for health care professionals working in NICU, procedure and CLABSI checklists, CLABSI and VAP bundles, hand hygiene compliance, use of clean gloves for regular handling, skin and oral care and other solutions to the barriers identified based on the fishbone analysis will be implemented in PDSA cycles until the target reduction is achieved. Compliance audits of the CLABSI and VAP bundles will be performed once every two weeks to validate the bundle implementation. The collected data will be documented and plotted as run charts and assessed on a weekly basis. Analysis will be done, and changes will be made accordingly through subsequent PDSA cycles. If the goal of reduction in the blood culture positivity rate by 30% is reached, then data collection will continue to the sustenance phase. 
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