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A clinical trial to study the effect of a medical device called "Embrace Infant Warmer" against the currently available method of thermal care in low birth weight neonates.

A randomized, active controlled, open label study to establish the non-inferiority of Embrace infant warmers against the standard of care in maintaining thermo stability of low birth weight neonates. ACRONYM : NEW (E) - Neonatal Easy Warming (Extended)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/04/001696
Enrollment
50
Registered
2011-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Maintenance of thermo stability in low birth weight neonates.

Interventions

Intervention1: EMBRACE INFANT WARMER: Embrace Infant Warmer to maintain thermo-stability in the range of 36.5 to 37.5&deg
C during the treatment phase that lasts for 4 hours as measured by axial or skin probe method. Control Intervention1: STANDARD OF CARE: Available standard of care at the site (This includes the radian

Sponsors

Cambree Life Improvement Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Parental agreement to participate, as documented on Informed Consent Document 2 Participant age of minimum 6 hours at the time of screening. 3 Low Birth Weight neonates ( weight more than or equal to 1500 grams to less than 1999 grams at time of screening) 4 Neonate body temperature not less than 36 oC 5 Neonate gestated for minimum 32 weeks.

Exclusion criteria

Exclusion criteria: 1 Malformation that adversely affects the temperature of the neonate 2 Parental refusal to participate. 3 Body temperature below 36 oC 4 Cardio respiratory distress 5 External supply of oxygen or intravenous fluids.

Design outcomes

Primary

MeasureTime frame
Maintaining of thermo-stability (36.5 ° C to 37.5° C), by the participating neonate at the end of the study treatment phase, as determined by axillary or skin care method.Timepoint: End of the study treatment phase that lasts for 4 hours in total—

Secondary

MeasureTime frame
2. Achievement of thermo-stability (36.5 ° C to 37.5° C), by the participating neonate at the end of the study treatment phase, as determined by axillary or skin care method.Timepoint: End of the study treatment phase that lasts in total for 4 hours;3. Number of interventions required to adjust the body temperature to normal (on reverting back to cold stress during the study treatment phase).Timepoint: During any time while participating in the study. The entire study participation phase is around 7.5 hours.;4. Neonate comfort in the bag.Timepoint: End of the study treatment phase that lasts in total for 4 hours;5. Ease of use by the neonate attendant/care giver.Timepoint: End of the study treatment phase that lasts in total for 4 hours—

Countries

India

Contacts

Public ContactDR SUDHIR BORGONHA

Cambree Life Improvement Technologies Private Limited

rpanicker@embraceinnovations.com09538768690

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 5, 2026