title: Keeping babies warm: a non-inferiority trial of a conductive thermal mattress.
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.
  
  
  BACKGROUND
  Clinical Trials Registry of India (CTRI/2010/091/002916 and CTRI/2011/04/001696).
authors: Department of Neonatology, St. John's Medical College, Bangalore, Karnataka, India.
authors: Swarna R
authors: SR
authors: Bhat
authors: Division of Neonatal-Developmental Medicine, Lucile Packard Children's Hospital at Stanford University School of Medicine, Palo Alto, California, USA.
authors: Nathan F
authors: NF
authors: Meng
authors: Department of Pediatrics, Cloud Nine Hospital, Bangalore, Karnataka, India.
authors: Kishore
authors: K
authors: Kumar
authors: Department of Neonatology, Manipal Hospital, Bangalore, Karnataka, India.
authors: Karthik N
authors: KN
authors: Nagesh
authors: Department of Pediatrics, Cloud Nine Hospital, Bangalore, Karnataka, India.
authors: Ashwini
authors: A
authors: Kawale
authors: Division of Neonatal-Developmental Medicine, Lucile Packard Children's Hospital at Stanford University School of Medicine, Palo Alto, California, USA.
authors: Vinod K
authors: VK
authors: Bhutani
mesh_terms: D001513:Beds; D001833:Body Temperature Regulation / Q000502:physiology; D005260:Female; D006361:Heating / Q000379:methods*; D006801:Humans; D007186:Incubators, Infant; D007230:Infant, Low Birth Weight / Q000502:physiology; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D015203:Reproducibility of Results; D013814:Thermal Conductivity; D016896:Treatment Outcome
keywords: Intensive Care; Neonatology; Technology; Temp Regulation