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.

Not Applicable

• Conditions: Health Condition 1: null- 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

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 100

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

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