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.
- Conditions
- CLINICALLY STABLE LOW-BIRTH-WEIGHT (LBW)NEONATES WEIGHING BETWEEN 1500 TO 2000 GRAMS WHO NEED THERMAL SUPPORT.
- Registration Number
- CTRI/2013/02/003439
- Lead Sponsor
- CAMBREE LIFE IMPROVEMENT TECHNOLOGIES PVT LTD
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 100
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.
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: oTachypnea oDyspnea oSubcostal in drawing oCyanosis •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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 30 DAYS OF STUDY TREATMENT PHASE (DAY 1 TO DAY 30) 2)Continued safety of the participants 30 DAYS OF STUDY TREATMENT PHASE (DAY 1 TO DAY 30) 3)Weight gain velocity across the two study arms 30 DAYS OF STUDY TREATMENT PHASE (DAY 1 TO DAY 30)
- Secondary Outcome Measures
Name Time Method • % incidence of normothermia across the 2 study arms •% incidence of AE and SAE across the 2 study arms
Trial Locations
- Locations (4)
BLDE college and Hospital
🇮🇳Bijapur, KARNATAKA, India
J.J.M Medical College
🇮🇳Davanagere, KARNATAKA, India
SSIMS
🇮🇳Davanagere, KARNATAKA, India
VIVEKANANDA MEMORIAL HOSPITAL
🇮🇳Mysore, KARNATAKA, India
BLDE college and Hospital🇮🇳Bijapur, KARNATAKA, IndiaDrSVPatilPrincipal investigator9900777903svpdr@yahoo.com