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Randomized Controlled Trial
. 2015 Jul;100(4):F309-12.
doi: 10.1136/archdischild-2014-306269. Epub 2015 Mar 19.

Keeping babies warm: a non-inferiority trial of a conductive thermal mattress

Swarna R Bhat  1 , Nathan F Meng  2 , Kishore Kumar  3 , Karthik N Nagesh  4 , Ashwini Kawale  3 , Vinod K Bhutani  2
Affiliations
Randomized Controlled Trial

Keeping babies warm: a non-inferiority trial of a conductive thermal mattress

Swarna R Bhat et al. Arch Dis Child Fetal Neonatal Ed. 2015 Jul.

Abstract

Background: External thermal support is critical for preterm or ill infants due to altered thermoregulation. Incubators are the gold standard for long-term support and have been adopted successfully in many countries. Alternatives such as radiant warmers, blankets and others are often used as standard of care (SoC) in resource-limited settings when infants are otherwise not in Kangaroo Mother Care (KMC).

Methods: In this pilot study, we evaluate the feasibility of a conductive thermal mattress (CTM) using phase change materials as a low-cost warmer. We conducted a prospective multicentre open-label randomised controlled trial to determine non-inferiority of this CTM to SoC warming practices in low birthweight infants. The primary outcome was maintenance of axillary temperature.

Results: We equally randomised 160 infants to CTM or SoC. The latter cohort continued to receive warmth by radiant warmers (n=48), blankets (n=18), warmed cradles (n=7) or KMC (n=7) before, during and subsequent to the study. CTM was deemed non-inferior since warmed babies had higher axillary temperature compared with SoC (mean increase 0.11±0.03°C SEM; p<0.001). Post hoc comparison to radiant warmers alone showed that CTM led to a higher axillary temperature (mean increase by 0.14±0.03°C SEM; p<0.001).

Conclusions: Short-term use of CTM compared with radiant warmers and other modes of warming is non-inferior to SoC and efficacious in maintaining body temperature. No adverse effects were reported. An extended multinational trial, preferably one that demonstrates longer-term thermoregulation, is warranted.

Trial registration number: Clinical Trials Registry of India (CTRI/2010/091/002916 and CTRI/2011/04/001696).

Keywords: Intensive Care; Neonatology; Technology; Temp Regulation.

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