Health Condition 1: null- CLINICALLY STABLE LOW-BIRTH-WEIGHT (LBW)NEONATES WEIGHING BETWEEN 1500 TO 2000 GRAMS WHO NEED THERMAL SUPPORT.
Conditions
Interventions
Intervention1: 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
Sponsors
CAMBREE LIFE IMPROVEMENT TECHNOLOGIES PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 armsTimepoint: 30 DAYS OF STUDY TREATMENT PHASE (DAY 1 TO DAY 30) | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ % incidence of normothermia across the 2 study arms â?¢% incidence of AE and SAE across the 2 study arms â?¢% increase in weight gain velocity in participants across the two treatment arms.Timepoint: 30 DAYS OF STUDY TREATMENT PHASE (DAY 1 TO DAY 30) | — |
Countries
India
Contacts
Public ContactDR SUDHIR BORGONHA
Cambree Life Improvement Technologies Private Limited
Outcome results
None listed