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CTRI Number  CTRI/2024/10/074761 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Quasi-experimental research 
Study Design  Other 
Public Title of Study   A project aimed at improving the admission temperature of newborns in the transition nursery. 
Scientific Title of Study   A Quality Improvement Initiative To Improve The Admission Temperature Of Neonates In The Transition Nursery. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ranganatha A Devaranavadagi  
Designation  DrNB Neonatology Resident 
Affiliation  Department of Neonatology, Manipal Hospital, Old Airport Road, Bangalore 
Address  Department of Neonatology, Manipal Hospital, Old Airport Road, Bangalore, Karnataka, India-560017

Bangalore
KARNATAKA
560017
India 
Phone  9972874332  
Fax    
Email  drranganath_a@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ranganatha A Devaranavadagi  
Designation  DrNB Neonatology Resident 
Affiliation  Department of Neonatology, Manipal Hospital, Old Airport Road, Bangalore 
Address  Department of Neonatology, Manipal Hospital, Old Airport Road, Bangalore, Karnataka, India-560017

Bangalore
KARNATAKA
560017
India 
Phone  9972874332  
Fax    
Email  drranganath_a@ymail.com  
 
Details of Contact Person
Public Query
 
Name  Ranganatha A Devaranavadagi  
Designation  DrNB Neonatology Resident 
Affiliation  Department of Neonatology, Manipal Hospital, Old Airport Road, Bangalore 
Address  Department of Neonatology, Manipal Hospital, Old Airport Road, Bangalore, Karnataka, India-560017

Bangalore
KARNATAKA
560017
India 
Phone  9972874332  
Fax    
Email  drranganath_a@ymail.com  
 
Source of Monetary or Material Support  
Department of Neonatology, Manipal Hospital, Old Airport Road, Bangalore, Karnataka, India-560017 
 
Primary Sponsor  
Name  Dr Ranganatha A Devaranavadagi 
Address  Department of Neonatology, Manipal Hospital, Old Airport Road, Bangalore, Karnataka, India-560017 
Type of Sponsor  Other [Self] 
 
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 Ranganatha A Devaranavadagi  Manipal Hospital  Deparment of Neonatology, Old Airport Road, Bangalore
Bangalore
KARNATAKA 
9972874332

drranganath_a@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee of Manipal Hospital, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Admission temperature of the normal newborn will be recorded after initiation of quality improvement initiative 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Not applicable  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  All the neonates born by LSCS at Manipal Hospital, Old Airport Road, Bangalore and shifting to Transition nursery. 
 
ExclusionCriteria 
Details  The Neonates requiring NICU admission.
The Neonates born by Vaginal delivery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Admission Temperature on arrival to Transition nursery.  Once the infant gets admitted to the transition nursery, the admission temperature will be recorded within 1 minute of shifiting 
 
Secondary Outcome  
Outcome  TimePoints 
None  Not applicable 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   12/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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  

Introduction: Temperature measurement and thermoregulation are important components of newborn care. The World Health Organization (WHO) has released a set of 10 procedures, including a warm chain, to address the global burden of hypothermia. 1 The WHO defines neonatal hypothermia as an axillary temperature below 36.5 °C among newborns aged below 28 days. 2 A direct relationship between the degree of hypothermia and the risk of infant mortality has been postulated in the studies. 3-5 For every 1° drop in the body temperature below 36.5 °C, studies have shown an increase in the risk of mortality in low-birthweight infants by 28%. 3 Data on hypothermia in late-preterm and term babies is limited, even in developed countries. 6

In our hospital, there is a designated area for babies who have undergone caesarean sections. This area serves as a transition zone until the mother is transferred to the postoperative room or ward. When the babies arrive in the transition nursery, their temperatures will be measured, and they will be placed under a radiant warmer with pulse oximeter monitoring. Once the mother is ready, direct breastfeeding will be started.

During the temperature audit of newborn babies admitted to the transition nursery, the mean temperature upon admission to the transition nursery was 35.5 C. This prompted us to initiate the quality improvement project to improve admission temperature in the transition nursery.

 

Aim:

To improve the admission temperature of Late preterm and Term babies admitted to Transition nursey.                  

                     

Material & methods

(i)             Study area: Transition Nursery, Manipal Hospital, Old Airport Road, Bengaluru.

 

(ii)           Study setting: Manipal Hospital, Old Airport Road, Bengaluru.

 

(iii)         Study design: Prospective study involving quality improvement project

 

(iv)          Study population: All Newborn admitted to Transition nursery

                                                                                                   

Methodology

Setting up Team: A quality improvement team will be formed consisting of Neonatology consultants, residents, and nursing staff. Babies requiring any interventions at birth will be excluded from the study.

Baseline phase: The baseline phase will be conducted where-in-admission temperature will be recorded upon admission to the Transition nursery and documented in the Excel sheet. A cause-and-effect analysis of the admission hypothermia will be formed using fishbone diagram based on the observation from our team.

Intervention phase:  Our QI team included consultant neonatologists, all neonatal residents, and nursing staff. One senior neonatologist will play an advisory role and oversee the implementation of the QI. The team will be reviewing the literature on evidence-based practices for thermal care and presenting the recommendations informally, which are then agreed upon or modified for local implementation. The general measures will be taken to implement the thermoregulation bundle, which includes orientation of pediatric and neonatal residents to the bundle recommendations and education of nurses with a power point presentation on various modes of heat loss, its prevention, and adverse effects of hypothermia. A systematic driven PDSA cycle will be conducted with the aim of improving admission temperature in Transition Nursery. With implementation of each PDSA cycle, the results measured in temperature will be analysed using Run chart. Team meeting will be conducted on a regular basis to oversee the quality improvement initiative results and to plan further accordingly.

 

Post-intervention phase: Admission temperature will be measured in the post-intervention phase, documented in Excel, and analysed using a run chart.

 

 

 

 

 

 

 
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