| CTRI Number |
CTRI/2017/11/010642 [Registered on: 27/11/2017] Trial Registered Prospectively |
| Last Modified On: |
15/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of new generation incubator versus radiant warmer in reducing postnatal weight loss in extremely premature infants |
|
Scientific Title of Study
|
Randomized controlled trial comparing new generation incubator versus radiant warmer for care of extremely low birth weight infants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandkishor S Kabra |
| Designation |
Consultant Neonatologist |
| Affiliation |
Surya Hospital |
| Address |
Department of Neonatology,
4th Floor, New Building,
Surya Hospital,
Junction of S V Road and Dattatray Road,
Santacruz West, Mumbai
Mumbai
MAHARASHTRA
400054
India |
| Phone |
|
| Fax |
|
| Email |
nskabra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPoulami Halder |
| Designation |
D.N.B Pediatrics trainee |
| Affiliation |
Surya Hospital |
| Address |
Department of Paediatrics,
Ground Floor, New Building,
Surya Hospital,
Junction of S V Road and Dattatray Road,
Santacruz West, Mumbai
Mumbai
MAHARASHTRA
400054
India |
| Phone |
|
| Fax |
|
| Email |
poulami.458@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandkishor S Kabra |
| Designation |
Consultant Neonatologist |
| Affiliation |
Surya Hospital |
| Address |
Department of Neonatology,
4th Floor, New Building,
Surya Hospital,
Junction of S V Road and Dattatray Road,
Santacruz West, Mumbai
Mumbai
MAHARASHTRA
400054
India |
| Phone |
|
| Fax |
|
| Email |
nskabra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Surya Hospital |
| Address |
Junction of S V Road and Dattatray Road,
Santacruz West, Mumbai
MAHARASHTRA
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrNandkishor S Kabra |
Surya Hospital |
NICU,4th Floor, New building,
Junction of S V Road and Dattatray Road,
Santacruz West, Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9820919271
nskabra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Surya Childrens medicare Pvt Ltd Medical ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neonates with birth weight less than 1000 grams admitted to NICU of Surya hospital within 24 hours of birth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Radiant warmer |
Fisher and Paykel - 900 series infant warmer- Servo controlled mode |
| Intervention |
New generation incubator |
Drager Isolette c2000.Double walled incubator with servo controlled temperature regulation |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Neonates admitted on Day0 of life with birth weight <1000 grams |
|
| ExclusionCriteria |
| Details |
Congenital anomalies incompatible with life
Neonates less than 24 weeks of gestation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken to regain birth weight |
From birth to 1 month of postnatal age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total fluid intake in first 3 days of life |
Birth to 3 days of postnatal age |
| Total fluid intake in first 7 days of life |
From birth to 7 days of postnatal age |
| Incidence of hypernatremia |
From birth to 3 days of postnatal age |
| Highest serum sodium level in first 3 days of life |
From birth to 3 days of postnatal age |
| Incidence of culture positive sepsis |
From birth till discharge |
| Incidence of hemodynamically significant PDA |
From birth to 7 days of postnatal age |
| Incidence of definite necrotising enterocolitis |
From birth till discharge |
| Incidence of IVH grade 3 or 4 |
From birth till discharge |
| Incidence of ROP requiring treatment |
From birth till discahrge |
| Incidence of Periventricular leucomalacia |
From birth till discharge |
| Incidence of chronic lung disease |
From birth till discharge |
| Duration of respiratory support |
From birth till discharge |
| Duration of hospital stay |
From birth till discharge |
| weight at discharge |
From birth till discharge |
| Length at discharge |
From birth till discharge |
| Head circumference at discharge |
From birth till discharge |
| All cause mortality |
From birth |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/11/2017 |
| Date of Study Completion (India) |
31/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Kabra NS, Umate SS, Halder P, Balasubramanian H. A randomized controlled trial to evaluate the efficacy and safety of a double-walled incubator compared to a radiant warmer in the care of extremely low-birth-weight infants. J Trop Pediatr. 2026 Jun 11;72(4):fmag040. doi: 10.1093/tropej/fmag040. PMID: 42275631. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of this RCT is to compare the effect of closed vs open care system of thermoregulating devices on various neonatal outcomes. The sample size is calculated using formula for the hypothesis of 2 parallel sample means. Average time taken to regain birth weight in less than 1000gms in radiant warmer in our NICU is 18 days. We hypothesize with use of incubator birth weight will be reached by 15 days. For a difference of 3 days with an error of 0.05 and beta error of 0.1 (power 90%) the estimated sample size is 22 in each group. |