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Warming adjuncts

Question Type:
Intervention
Full Question:
Among preterm neonates who are under radiant warmers in the hospital delivery room (P), does increased room temperature, thermal mattress, or another intervention (I), compared with plastic wraps alone (C), reduce hypothermia (<36.0) on admission to NICU (O)?
Consensus on Science:
Thermal Mattress Plus Plastic Wrap Plus Radiant Warmer (I) Versus Plastic Wrap Plus Radiant Warmer For the critical outcome of hypothermia (temperature less than 36.0°C) at NICU admission, we identified low-quality evidence (downgraded for serious risk of bias) from 1 randomized controlled trial (McCarthy 2013, e135) enrolling 72 preterm infants of less than 32 weeks of gestation showing no benefit to addition of a thermal mattress to the use of plastic wrap and radiant warmer (RR, 1.89; 95% CI, 0.18–19.95). Four observational studies (low-quality evidence, downgraded for serious risk of bias) (Ibrahim 2010, 795; Singh 2010, 45; Chawla 2011, 780; Billimoria 2013, 455) including 612 patients of less than 32 weeks of gestation showed benefit to the addition of the thermal mattress (OR, 0.27; 95% CI, 0.18–0.42). For the important outcome of hyperthermia (temperature greater than 38.0°C) at admission, we have identified low-quality evidence (downgraded for serious risk of bias) from the same randomized controlled trial(McCarthy 2013, e135) and 4 observational studies(Singh 2010, 45; Chawla 2011, 780; McCarthy 2011, 1534; Billimoria 2013, 455) including 426 patients showing no harm from the thermal mattress (RR, 3.78; 95% CI, 0.86–16.60 and OR, 6.53; 95% CI, 0.80–53.30). Environmental Temperature 26°C or Greater Plus Plastic Wrap Plus Radiant Warmer (I) Versus Plastic Wrap Plus Radiant Warmer (C) For the critical outcome of hypothermia (temperature less than 36.0°C) at NICU admission, we identified no studies addressing this intervention alone. For the important outcome of hyperthermia (temperature greater than 38.0°C) at admission, we identified low-quality evidence (downgraded for serious risk of bias) from 1 observational study(Knobel 2005, 304) including 40 patients of less than 29 weeks of gestation showing no harm from increasing the environmental temperature 26°C or greater (OR, 8.45; 95% CI, 0.37–182.58). Heated and Humidified Gases Plus Plastic Wrap Plus Radiant Warmer (I) Versus Plastic Wrap Plus Radiant Warmer (C) For the critical outcome of hypothermia (temperature less than 36.0°C) at NICU admission, we identified very-low-quality evidence (downgraded for serious risk of bias) from 1 randomized controlled trial(Meyer 2001, 395-401)enrolling 203 patients of less than 32 weeks of gestation showing no benefit (RR, 0.64; 95% CI, 0.31–1.35), and 1 observational study (low-quality evidence)(te Pas 2010, e1427-e1432) including 112 patients of less than 33 weeks of gestation showing benefit to the use of heated and humidified gases and to the use of plastic wrap and the radiant warmer (OR, 0.20; 95% CI, 0.08–0.47). For the important outcome of hyperthermia (temperature greater than 38.0°C) at admission, we identified low-quality evidence (downgraded for serious risk of bias) from the same observational study showing no harm (OR, not estimable).Plastic Wrap Plus Wrap Plus Radiant Warmer (I) Versus Plastic Wrap Plus Radiant Warmer (C) For the critical outcome of hypothermia (temperature less than 36.0°C) at NICU admission, we identified very-low-quality evidence (downgraded for serious risk of bias) from 1 randomized controlled trial (Doglioni 2014, 261) enrolling 100 patients of less than 29 weeks of gestation showing no benefit to the addition of wrapping (RR, 0.60; 95% CI, 0.24–1.53). For the important outcome of hyperthermia (temperature greater than 38.0°C) at admission, we identified low-quality evidence (downgraded for serious risk of bias) from the same randomized controlled trial showing no harm (RR, 0.33; 95% CI, 0.01–7.99). Combination of Interventions (Environmental Temperature 23°C to 25°C Plus Plastic Wrap Without Drying Plus Cap Plus Thermal Mattress Plus Radiant Warmer) Versus Plastic Wrap Plus Radiant Warmer (C)For the critical outcome of hypothermia (temperature less than 36.0°C) at admission, we identified very-low-quality evidence (downgraded for serious risk of bias) from 4 observational studies (DeMauro 2013, e1018; Lee 2014, e1378; Pinheiro 2014, e218; Russo 2014, e1055) enrolling 9334 patients of less than 35 weeks of gestation showing benefit from using a combination of interventions (ie, environmental temperature 23°C to 25°C plus plastic wrap without drying plus cap plus thermal mattress plus radiant warmer; OR, 0.40; 95% CI, 0.35–0.46). For the important outcome of hyperthermia (temperature greater than 38.0°C) at admission, we have identified low-quality evidence (downgraded for serious risk of bias) from 3 observational studies (DeMauro 2013, e1018; Lee 2014, e1378; Pinheiro 2014, e218) enrolling 8985 patients showing no harm to the combination of interventions (OR, 1.12; 95% CI, 0.82–1.52).
Treatment Recommendation:
Among newly born preterm infants of less than 32 weeks of gestation under radiant warmers in the hospital delivery room, we suggest using a combination of interventions, which may include environmental temperature 23°C to 25°C, warm blankets, plastic wrapping without drying, cap, and thermal mattress to reduce hypothermia (temperature less than 36.0°C) on admission to NICU (weak recommendation, very-low-quality evidence). We suggest that hyperthermia (greater than 38.0°C) be avoided due to the potential associated risks (weak recommendation, very-low-quality evidence).Values, Preferences, and Task Force Insights We place value on the large numbers enrolled in the observational studies and consistent direction of effect.Because many of the studies used multiple strategies, it was not possible to identify the different specific interventions, which are effective in maintaining temperature. There was concern whether the recommendation should be so strong when the CIs for hyperthermia (0.80–53.30) comprising 3 studies are so wide, raising the potential chance for harm. A strong recommendation was made because of the large numbers in the studies and the consistent direction of effect. There was concern about 1 randomized thermal mattress trial, which was stopped for safety issues because of hyperthermia. However, this is the only study that has demonstrated an adverse effect with small numbers, suggesting some unclear negative (possible environmental) effect. In the treatment recommendation, it was suggested to add the words may include before the word combination.
CoSTR Attachments:
BIAStrevisanuto_n.xlsx    
evidence profile table.amended31decAdjuncFinal14jan2015(3)_n.docx    
GRADEGRID.13th Jan sample (3)ADJUNT.doc    

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