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CTRI Number  CTRI/2013/09/003969 [Registered on: 11/09/2013] Trial Registered Retrospectively
Last Modified On: 29/04/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Capacity building of accompanying attendants of a sick newborn for delivery of care to improve neonatal outcomes in a hospital setting  
Scientific Title of Study   Effect of capacity building and empowering the accompanying parent attendants, for delivery of ‘package of care’ to their sick neonate admitted to a tertiary level referral nicu – special reference to nosocomial infection rate: a randomized controlled trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ankit verma 
Designation  PG student 
Affiliation  PGIMER and Dr RML Hospital 
Address  C/O, Dr Arti Maria, Room No. 239, Department of Paediatrics and Neonatology, Dr RML Hospital, Baba Kharak Singh Marg, Delhi

Central
DELHI
110001
India 
Phone  9868979309  
Fax    
Email  ankitvmmc@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Arti Maria 
Designation  Associate Professor 
Affiliation  PGIMER and Dr RML Hospital 
Address  Room No. 239, Department of Paediatrics and Neonatology, Dr RML Hospital, Baba Kharak Singh Marg, Delhi

Central
DELHI
110001
India 
Phone  9818618586  
Fax    
Email  artimaria@gmail.com  
 
Details of Contact Person
Public Query  
Name  ankit verma 
Designation  PG student 
Affiliation  PGIMER and Dr RML Hospital 
Address  C/O, Dr Arti Maria, Room No. 239, Department of Paediatrics and Neonatology, Dr RML Hospital, Baba Kharak Singh Marg, Delhi


DELHI
110001
India 
Phone  9868979309  
Fax    
Email  ankitvmmc@yahoo.co.in  
 
Source of Monetary or Material Support  
ankit verma 
 
Primary Sponsor  
Name  PGIMER Dr RML Hospital 
Address  PGIMER and Dr. RML Hospital , Baba Kharak Singh Marg, New Delhi 110001 
Type of Sponsor  Research institution and hospital 
 
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 
ankit verma   referral NICU   C/3 F, Casuality Building , PGIMER and Dr. RML Hospital
Central
DELHI 		 9868979309

ankitvmmc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dr. RMLH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  nosocomial infection rate studied,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control group  this included the sick newborns who after randomization belonged to the group receiving clinical care provided by the nurses and doctors as usual. 
Intervention  training module  Intervention was supervised delivery of a package of care to the sick newborn by his / her parent attendants in addition to the standard care provided by the nurse or doctor in nursery. This was achieved by training the parent attendant accompanying their sick neonate, through an audio visual module. This module pertains to delivery of a package of care by the attendant with special emphasis on handwashing and prevention of infection. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  all neonates admitted to tertiary level nursery of RMLH accompanied by atleast 2 parent attendants who were willing to participate in study  
 
ExclusionCriteria 
Details  refusal to consent, haemodynamically unstable babies, with gross major malformation, twins or triplets where more than 2 parent attendants with individual baby were not available 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Culture positive nosocomial infection rate defined as number of episodes of culture proven nosocomial infections per thousand baby days of admission.
 		 january 2011 - marcn 2012  
 
Secondary Outcome  
Outcome  TimePoints 
mortality  january 2011 - marcn 2012 
Median duration of hospital stay.   january 2011 - marcn 2012  
Culture negative nosocomial infection rate defined as number of episodes of culture negative nosocomial infections per thousand baby days of admission.  january 2011 - marcn 2012  
 
Target Sample Size   Total Sample Size="2157"
Sample Size from India="2157" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
This was a randomised controlled trial to study the impact of parent-attendant involvement in providing a package of care to their sick neonate, on nosocomial infection in a tertiary level neonatal intensive care unit with an overarching aim to adapt the principles of family centred care to decrease the nosocomial infection in a tertiary level referral nursery.We hypothesised that translating and adapting principles of family centred care to an operational and culturally sensitive module which empowers families to take care of their sick baby in nursery, results in decreasing nosocomial infection rate in a tertiary level referral nursery by 50%. 
295 babies were randomized into 148 in intervention and 147 in control group. Babies in study group received intervention in form of a supervised delivery of a package of care to their sick newborn by his / her parent attendants through an indigenously prepared audio visual module. This intervention in the study group was in addition to the standard care provided by the nurses/doctors in nursery as in the control group.  Primary outcome variable was difference in culture positive nosocomial infection rate in the two groups.
 
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