| 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
|
|
|
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
|
|
|
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.
|