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CTRI Number  CTRI/2013/02/003439 [Registered on: 28/02/2013] Trial Registered Retrospectively
Last Modified On: 04/12/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to determine the efficacy of Embrace Care device against the currently available solutions in maintaining normal body temperature in low-birth-weight babies in a home setting. 
Scientific Title of Study   A randomized, open-label, active controlled study to determine the efficacy of the Embrace Care in maintaining normothermia (36.5°C to 37.5°C) in low-birth-weight (LBW) neonates (1500 to 2000 grams) as compared to the currently available routine practice of attempting to maintain normothermia in the community setting. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
REIW 2012-001  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kumar GS 
Designation  Principal Investigator 
Affiliation  Vivekananda Memorial Hospital 
Address  Department of Paediatrics, Vivekananda Memorial Hospita, Hanchipura Road,Saragur, HD Kote Taluk,Mysore District, Karnataka-571121
Same as address 1
Mysore
KARNATAKA
571121
India 
Phone  9686929615  
Fax  0821265412  
Email  drgsk4u@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kamalika Chattopadhyay 
Designation  Lead,Clinical Research 
Affiliation  Cambree Life Improvement Technologies Private Limited 
Address  18/19,Platinum Square, Leonard Lane, Richmond Town, Bangalore-560025
Same as address 1
Bangalore
KARNATAKA
560025
India 
Phone  9591992288  
Fax  08041125468  
Email  kchattopadhyay@embraceinnovations.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  DR SUDHIR BORGONHA 
Designation  MEDICAL DIRECTOR 
Affiliation  Cambree Life Improvement Technologies Private Limited 
Address  18/19,Platinum Square, Leonard Lane, Richmond Town, Bangalore-560025
Same as address 1
Bangalore
KARNATAKA
560025
India 
Phone  09686897400  
Fax  08041125468  
Email  sborgonha@embraceinnovations.com  
 
Source of Monetary or Material Support  
CAMBREE LIFE IMPROVEMENT TECHNOLOGIES PVT. LTD 
 
Primary Sponsor  
Name  CAMBREE LIFE IMPROVEMENT TECHNOLOGIES PVT LTD 
Address  18/19,PLATINUM SQUARE,LEONARD LANE,RICHMOND TOWN, BANGALORE - 560025, KARNATAKA STATE, INDIA 
Type of Sponsor  Other [MEDICAL DEVICE COMPANY] 
 
Details of Secondary Sponsor  
Name  Address 
NOT APPLICABLE  NOT APPLICABLE 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSVPatil  BLDE college and Hospital  Department of Pediatrics, BLDE University, Smt. Bagaramma Sajjan Campus, Bijapur-586103, Karnataka, INDIA
Bijapur
KARNATAKA 		 9900777903

svpdr@yahoo.com 
Dr Guru Prasad  J.J.M Medical College  Department of Pediatrics, J.J.M Medical College Davangere-577004, P.O. Box.301.Karanataka (India)
Davanagere
KARNATAKA 		 9844065889

dr_g_gp@yahoo.com 
Dr Prasad  SSIMS  Department of Pediatrics, S.S.I.M.S & R.C,Jnanashankara, NH 4 Bypass,Post Box No: 1, Bypass Road,Davangere - 577005
Davanagere
KARNATAKA 		 9243312890

umaprasadbs@yahoo.com 
DR KUMAR GS   VIVEKANANDA MEMORIAL HOSPITAL  VIVEKANANDA MEMORIAL HOSPITAL, HANCHIPURA ROAD,SARAGUR, HD KOTE TALUK,MYSORE DISTRICT, KARNATAKA-571121, INDIA
Mysore
KARNATAKA 		 9886077945
8228265413
drgsk4u@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethical Committee,J.J.M Medical College,Davangere  Approved 
Institutional Ethics Committee for Human Research at BLDE Universitys Shri BM Patil Medical College Bijapur  Approved 
Institutional Ethics Committee,S.S Institute of Medical Science and Research Centre,Davangere  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  CLINICALLY STABLE LOW-BIRTH-WEIGHT (LBW)NEONATES WEIGHING BETWEEN 1500 TO 2000 GRAMS WHO NEED THERMAL SUPPORT.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Blankets  Standard of care (SOC hereafter) means that the participating neonates are wrapped up in blankets for a period of 30 calendar days. Kangaroo Mother Care (KMC) and breastfeeding may be provided at any time in either arm. 
Intervention  Embrace Care device  The participating neonates enrolled in the Embrace Care device arm will be placed in the device and monitored for a period of 30 calendar days. The mother and other family members (care givers) will be thoroughly trained on the correct storage, handling and maintenance of the device. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  1)Parental consent for participation
2)Minimum 6 hours of age and not more than 28 days old
3)Not less than 1500 grams and not more than 2000 grams
4)Body temperature not less than 36.0°C
5)Minimum 34 weeks of gestation
6)Mother clinically stable and free from any infection
7)Normal skin conditions
 
 
ExclusionCriteria 
Details  1)External supply of oxygen
2)External supply of intravenous fluids
3)Ongoing treatment for cardiovascular distress characterized by:
• Innocent murmurs particularly if it is nonmusical
• Loud coarse systolic murmur
• Murmur of a ventricular septal defect
• Patent ductus murmur
• Discoloration of the buccal mucous membranes
4)Ongoing treatment for Respiratory distress syndrome characterized by:
o Tachypnea
o Dyspnea
o Subcostal in drawing
o Cyanosis
• Grunting
• Murmurs
5)Ongoing treatment for atelectasis with or without hyaline membrane disease
6)Ongoing treatment for pulmonary haemorrhage
7)Ongoing treatment for intracranial bleeding secondary to anoxia
8)Ongoing treatment for intracranial bleeding secondary to birth trauma
9)Ongoing treatment for pneumonia
10)Ongoing treatment for neonatal sepsis
11)Ongoing treatment for asphyxia at birth
12Ongoing treatment for other infections
13)Ongoing treatment for existing malformations that may adversely affect body temperature
14)Ongoing treatment for jaundice
15)Ongoing treatment for anemia
16)Ongoing treatment of low blood glucose
17)Ongoing treatment for necrotizing enterocolitis
18)Ongoing treatment for intraventricular bleeding
19)Ongoing treatment for metabolic acidosis
20)Ongoing treatment for Retinopathy of Prematurity
21)Ongoing treatment for bleeding diathesis
22)Ongoing treatment for shock
23)Ongoing treatment for hemodynamic instability characterized by:
a. Tachypnea
b. Dyspnea
c. Subcostal indrawing
a. Apnea
b. Requirement for oxygen
c. Convulsions
d. Fever (>37.50C) or low temperature (<35.50C)
e. Abnormal state of consciousness
f. Abdominal distension
8) Inadequate breast feeding:
a. Feeding rate less than 8 times in 24 hours
b. Participant does not wet as frequently as feeding
c. Poor attachment and ineffective suckling
d. Participant tires while feeding
e. Mother stops feeding before completion
f. Mother has breast engorgement
g. Mother has sore nipple
24)Ongoing treatment for orthopnea
25)Ongoing treatment for liver enlargement
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Comparison of the efficacy of Embrace Care in maintaining normothermia (36.5°C to 37.5°C) in LBW neonates (1500 to 2000 grams) against SOC in maintaining normothermia in the community setting.
2)Continued safety of the participants
3)Weight gain velocity across the two study arms  		 30 DAYS OF STUDY TREATMENT PHASE (DAY 1 TO DAY 30) 
 
Secondary Outcome  
Outcome  TimePoints 
• % incidence of normothermia across the 2 study arms
•% incidence of AE and SAE across the 2 study arms
•% increase in weight gain velocity in participants across the two treatment arms. 		 30 DAYS OF STUDY TREATMENT PHASE (DAY 1 TO DAY 30) 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/02/2013 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not applicable now 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

The Embrace Care is designed and intended to be used by mothers a rural home setting. As such, the device has many features specifically catering to meet the needs of the user in this context and is designed for ease and simplicity of use. It only requires pen torch batteries and boiling water to operate, and is engineered to be extremely safe for both the baby and user

Justification for the current study:

 The REIW 2012-001 is a successor of its preceding REIW 2011-001 study that analyzed the incidence of maintenance of normothermia across the two treatment arms during the 10 days of the study conduct phase statistically significant as concluded via a test for difference between population proportions by checking against alternate hypothesis that incidence of normothermia in the REIW arm ~= incidence of normothermia in the SOC arm and null hypothesis being that difference between incidences is zero. (Proportion of incidences of 0.9380 in the Embrace Care arm vs. 0.9610 in the standard of care arm with a p value of 0.0490).  The mean percentage weight gain in the Embrace Care arm (6.84) is lesser than the standard of care (or control) arm (10.70) at a statistically significant level (p-value 0.0209). This is concluded via the test for difference in mean percentage weight gain across the two treatment arms.

Detailed analysis to identify the cause for the same attributed to blankets being used in conjunction with regular temperature monitoring and adjustment of the number of layers suitably in the standard of care arm which is not a common practice in the actual community setting. Moreover maximum enrollments happened in months when ambient temperature was high. This thus suggested for the conduct of a multicenter clinical study to upscale the device application and determine its efficacy against the currently available routine practice of attempting to maintain normothermia in the community setting.

 

The REIW 2012-001 study proposed to be conducted on a maximum population of 130 participants who meet the study enrollment criteria has recruited total 37 participants across 4 participating centres. Recruitment is currently on hold. Analysis of the data collected will enable decisions on the next steps.


As this device does not come under the list of notified medical device ,so approval from DCGI for the protocol is not required,however acknowledgement from DCGI has been obtained on 17 Dec 2012.


 
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