| CTRI Number |
CTRI/2024/10/076075 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| 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
|
Comparing the incidence of sepsis in NICU babies with birth weight less than 1500 grams who receive daily sponging versus those who do not receive daily sponging |
|
Scientific Title of Study
|
Comparing the effect of no sponging versus daily sponging on incidence of late onset neonatal sepsis among very low birth weight (VLBW) neonates in neonatal intensive care unit: An open label randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arti Maria |
| Designation |
Professor and Dean |
| Affiliation |
ABVIMS and Dr. RML Hospital New Delhi |
| Address |
Dr RML hospital
ABVIMS and Dr. RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9818618586 |
| Fax |
|
| Email |
artimaria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arti Maria |
| Designation |
Professor and Dean |
| Affiliation |
ABVIMS and Dr. RML Hospital New Delhi |
| Address |
Dr RML hospital
ABVIMS and Dr. RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9818618586 |
| Fax |
|
| Email |
artimaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shobhna Sharma |
| Designation |
DM Senior Resident |
| Affiliation |
ABVIMS and Dr. RML Hospital New Delhi |
| Address |
Dr RML hospital
ABVIMS and Dr. RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
7703956842 |
| Fax |
|
| Email |
drsharma220895@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr RML Hospital, New Delhi, Delhi-110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Neonatology, ABVIMS and Dr RML Hospital, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Arti Maria |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. RML Hospital, New Delhi |
Department of Neonatology, Room number 9
New Delhi
DELHI |
9818618586
artimaria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, ABVIMS, Dr. RML Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P071||Other low birth weight newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Daily routine sponging |
In this group, babies will be sponged with lukewarm water of temperature 38°© in cephalocaudal manner. Duration of sponging will be 5-7 min. Following the intervention, temperature, salivary cortisol and PIPP-r score will be assessed.daily and weekly weight gain will be compared between both the groups, this will be continued till discharge/ death of the enrolled subject.
|
| Intervention |
No sponging |
In this group, babies will be cleaned only when visibly soiled and no daily routine sponging will be done |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
1. All VLBW neonates admitted to NICU within 72 hours of life.
2. With informed written consent. |
|
| ExclusionCriteria |
| Details |
1. Known severe congenital/ chromosomal abnormalities.
2. Hemodynamic instability. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of late onset neonatal sepsis among VLBW neonates in neonatal intensive care unit in both the groups. |
Episodes late onset neonatal sepsis will be assessed in a continuum and compared among both the groups whenever the baby gets discharged. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypothermia in both the groups. |
Every 10 minutes till temperature normalizes. |
Rate of weight gain in both the groups.
|
Every week till discharge. |
| Physiological and behavioral responses to daily sponging. |
1 minute after intervention. |
| Rise in salivary cortisol levels in daily sponging group. |
20 minutes after intervention on day 3 of life. |
| Composite incidence of mortality or sepsis. |
At discharge. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| 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="1"
Months="3"
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
|
- All inborn VLBW neonates and outborn VLBW neonates admitted in NICU within 72 hours of life will be eligible for the study. All eligible infants will be assessed for presence of any one or more of the exclusion criteria. If none of the exclusion criteria are met then these infants will be enrolled in the study. Eligible infants will be randomly assigned into two groups. No sponging and Routine sponging.
- The first sponging will be done once the newborn has achieved cardiorespiratory and thermal stability. A standardized procedure of sponging will be taught to all the nursing staff of NICU.
- For the purpose of the study, late onset sepsis will include clinical sepsis, probable sepsis and culture proven sepsis. Multiplex PCR for bacterial detection will be taken as a surrogate marker for culture positivity.
- Temperature will be recorded using peripheral and central thermistor probes installed in the incubators. When babies are in incubators with only one thermistor probe, peripheral temperature will be assessed by comparing it with the central temperature using back of the hand. Three standard measurements will be taken for each baby at 5min before sponging, 5 and 10 min after sponging. In babies whose temperature is not stabilized by 10 min, temperature will be checked every 10 min till temperature becomes 36.5 degree Celsius.
- Daily weight will be monitored using digital weighing scale and weekly weight gain will be compared.
- For assessing the physiological and behavioral components of stress, Premature infant pain profile PIPP-r will be used.
- Saliva will be collected for salivary cortisol measurements before sponging and 20 minutes following sponging on day 3 of life. Sponging will be done at 9AM to decrease the influence of natural cortisol peak occurring between 6AM-8AM, on salivary cortisol in sponging group. First sample will be collected for obtaining the baseline levels prior to the intervention and second sample will be collected post-intervention in the sponging group. Saliva samples from the non- sponged group will also be collected parallelly for baseline comparison.
- Composite outcome in terms of incidence of mortality or sepsis will be compared in both the groups.
|