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Dallas 2015
TFQO: EVREVs: de Almeida, Maria Fernanda COI# Trevisanuto, Daniele COI#Taskforce: Neonatal
Warming Adjunts #599Among 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)?
Dallas 2015COI Disclosure (specific to this systematic review)
EVREV COI# De Almeida, Maria FernandaCommercial/industry
• does not have any commercial/industry or potential intellectual conflicts
Potential intellectual conflicts• Coordinator of Brazilian NRP; Portuguese version of Textbook on
Neonatal Resuscitation & DVD-ROOM – AAP & AHA 6th edition
EVREV COI# Trevisanuto, Daniele Commercial/industry
• Does not have any commercial/industry or potential intellectual conflicts
Potential intellectual conflicts• Co-author of two (one excluded) of the examined papers
Dallas 20152010 CoSTR
CONSENSUS on SCIENCE: “In the absence of polythene wrapping, use of exothermic mattresses maintained the temperature of newborn infants weighing <1500 g within the normal range (LOE2 123). A combination of exothermic mattresses and polythene wrapping during resuscitation is the most effective strategy to avoid hypothermia but may increase the risk of hyperthermia (LOE3 124). Delivery room temperatures of at least 26C for newborns at <28 weeks’ gestation in combination with polythene wraps or bags maintained temperatures most effectively (LOE4 125; LOE3 126).”TREATMENT RECOMMENDATION: “Newborn infants of <28 weeks’ gestation should be completely covered in a polythene wrap or bag up to their necks without drying immediately after birth and then placed under a radiant heater and resuscitated or stabilized in a standard fashion. Infants should be kept wrapped until admission and temperature check. Hyperthermia should be avoided. Delivery room temperatures should be at least 26C for infants of <28 weeks’ gestation.”
Dallas 2015C2015 PICO
Population: inborn preterm infants under radiant warmers in the hospitalIntervention: warmer mattress, environmental room >=26oC, heated and humidified gases; plastic cap; combination of interventionsComparison: plastic wrap Outcomes: (7 critical) hypothermia <36.0oC (6 important) hyperthermia >=38.0oC
Dallas 2015Inclusion/Exclusion& Articles Found
Inclusions/Exclusions Inclusion Criteria: Randomized studies, studies with concurrent controls or with historical controls and meta-analysis. Exclusion Criteria: Review articles, animal studies and studies that did not specifically answer the question. Unpublished studies, and studies only published in abstract form, unless accepted for publication were also excluded.
14 finally evaluated3 RCT 11 observational studies
Dallas 20152015 Proposed Treatment Recommendations
Among newly born preterm infants <32 weeks gestation under radiant warmers in the hospital delivery room, we recommend using a combination of interventions (environmental temperature 23-25oC, warm blankets, plastic body and head wrapping without drying, cap, thermal mattress) to reduce hypothermia (<36.0oC) on admission at NICU (strong recommendation, moderate quality of evidence). Values and preferences statement: in making this recommendation we also place a value on avoiding hyperthermia (>38.0oC) during application of all above interventions.
Dallas 2015 Risk of Bias in studies
Randomized Controled Trials
Dallas 2015 Risk of Bias in studies
Observational Studies
Dallas 2015Evidence profile table 1
Author(s): Trevisanuto, Daniele; de Almeida, Maria FernandaDate: 13 Jan 2015Question: Does WARMING MATTRESS + Plastic Wrap vs Plastic Wrap be used in preterm neonates under radiant warmers? Settings: hospital delivery room Bibliography: Billimoria, J Perinat Med 2013, 455; Chwala, J Perinatol 2011, 780; Ibrahim, Eur J Pediatr 2010, 795; McCarthy, Acta Paediatr 2011, 1534; McCarthy, Pediatrics 2013, e135; Singh, J Perinatol 2010, 45.
QUALITY ASSESSMENT NO OF PATIENTSTS EFFECT
Qual-ity
Impor-tance
NoStudies
DesignRisk of
bias
Inconsistency
Indirectness
Im-precisio
n
Other
MATTRESS+
wrap+heater
wrap+heater
Relative(95% CI)
Absolute
TEMPERATURE<36.0°C
1 RTCserious
1
no serious
no serious
very serious
2
none2/37
(5.40%)1/35
(2.85%)RR = 1.89
(0.18-19.95)
30 more per 1000[from 70 fewer to 120
more]
ÅÅOOLOW
CRITICAL
4Observa-
tionalserious serious serious Serious none
81/350 (23.1%)
119/262 (45.4%)
OR = 0.27(0.18-0.42)
210 fewer per 1000[from 270 fewer to 140
fewer]
ÅOOOVERY LOW
CRITICAL
TEMPERATURE>38.0°C
1 RTCserious
1
no serious
no serious
very serious
2
none8/37
(21.61%)2/35
(5.71%)RR = 3.78
(0.86-16.60)
160 more per 1000 [from 10 more to 310
more]
ÅÅOOLOW
IMPORTANT
4Observa-
tionalserious serious serious serious none
13/254 (5.11%)
0/172 (0.00%)
OR = 6.53(0.80-53.30)
40 more per 1000 [from 30 fewer to 100
more]
ÅOOOVERY LOW
IMPORTANT
1 Lack of blinding2 Trial was stopped early; loss of study power for outcome Temperature<36.0°C
Dallas 2015Evidence profile table 2
Author(s): Trevisanuto, Daniele; de Almeida, Maria FernandaDate: 13 Jan 2015Question: Does ENVIRONMENTAL TEMPERATURE >=26.0O C + Plastic Wrap vs Plastic Wrap be used in preterm neonates under radiant warmers? Settings: hospital delivery room Bibliography: Knobel, J Perinatol 2005, 304.
QUALITY ASSESSMENT NO OF PATIENTSTS EFFECT
Qual-ity
Impor-tance
NoStudies
DesignRisk of
bias
Inconsistency
Indirectness
Im-precisio
n
Other
ROOM TEMP.
>=26oC + wrap+heater
wrap+heater
Relative(95% CI)
Absolute
TEMPERATURE<36.0°C
1Observa-
tionalserious serious serious serious none Not available
Not available
ÅOOOVERY LOW
CRITICAL
TEMPERATURE>38.0°C
1Observa-
tionalserious serious serious serious none
1/10 (10.00%)
0/30 (0.00%)
OR = 8.45(0.37-
182.58)
100 more per 1000[from 110 fewer to 310
more]
ÅOOOVERY LOW
IMPORTANT
Dallas 2015Evidence profile table 3
Author(s): Trevisanuto, Daniele; de Almeida, Maria FernandaDate: 13 Jan 2015Question: Does HEATED UMIDIFIED GASES + Plastic Wrap vs Plastic Wrap be used in preterm neonates under radiant warmers? Settings: hospital delivery room Bibliography: Meyer, J Pediatr 2014 [epub ahead of print]; te Pas, Pediatrics 2010, e1427.
QUALITY ASSESSMENT NO OF PATIENTSTS EFFECT
Qual-ity
Impor-tance
NoStudies
DesignRisk of
bias
Inconsistency
Indirectness
Im-precisio
n
Other
HEATED GASES +wrap+heater
wrap+heater
Relative(95% CI)
Absolute
TEMPERATURE<36.0°C
1 RCTserious
1
no serious
no serious
very serious
2
none10/100
(10.00%)16/103
(15.53%)RR = 0.64 (0.31-1.35)
60 fewer per 1000
[from 150 fewer to 40 more]
ÅÅOOLOW
CRITICAL
1Observa-
tionalserious serious serious serious none
10/54 (18.51%)
31/58 (53.44%)
OR = 0.20 (0.08-0.47)
350 fewer per 1000[from 510 fewer to 180
fewer]
ÅOOOVERY LOW
CRITICAL
TEMPERATURE>38.0°C
1Observa-
tionalserious serious serious serious none
0/54 (0.00%)
0/58 (0.00%)
OR = not estimable
ÅOOOVERY LOW
IMPORTANT
1 Lack of blinding2 Loss of study power for outcome Temperature<36.0°C
Dallas 2015Evidence profile table 4
Author(s): Trevisanuto, Daniele; de Almeida, Maria FernandaDate: 13 Jan 2015Question: Does PLASTIC CAP + Plastic Wrap vs Plastic Wrap be used in preterm neonates under radiant warmers? Settings: hospital delivery room Bibliography: Doglioni, J Pediatr 2014, 261.
QUALITY ASSESSMENT NO OF PATIENTSTS EFFECT
Qual-ity
Impor-tance
NoStudies
DesignRisk of
bias
Inconsistency
Indirectness
Im-precisio
n
Other
PLASTIC CAP +wrap+heater
wrap+heater
Relative(95% CI)
Absolute
TEMPERATURE<36.0°C
1 RCTserious
1
no serious
no serious
very serious
2
none6/50
(12.00%)10/50
(20.00%)RR = 0.60 (0.24-1.53)
80 fewer per 1000 [from 220 fewer to 60
more]
ÅÅOOLOW
CRITICAL
TEMPERATURE>38.0°C
1 RCTserious
1
no serious
no serious
very serious
2
none0/50
(0.00%)1/50
(2.00%)RR = 0.33 (0.01-7.99)
20 fewer per 1000[from 70 fewer to 30 more]
ÅÅOOLOW
IMPORTANT
1 Lack of blinding2 Loss of study power for outcome Temperature<36.0°C
Dallas 2015Evidence profile table 5
Author(s): Trevisanuto, Daniele; de Almeida, Maria FernandaDate: 13 Jan 2015Question: Does COMBINATION OF INTERVENTIONS (environmental temperature 23-25oc, warm blankets, plastic body and head wrapping without drying, cap, thermal mattress) vs Plastic Wrap be used in preterm neonates under radiant warmers? Settings: hospital delivery room Bibliography: DeMauro, Pediatrics 2013, e1018; Lee, Pediatrics 2014, e1378; Pinheiro, Pediatrics 2014, e218; Russo, Pediatrics 2014, e1.
QUALITY ASSESSMENT NO OF PATIENTSTS EFFECT
Qual-ity
Impor-tance
NoStudies
DesignRisk of
bias
Inconsistency
Indirectness
Im-precisio
n
Other
COMBINA-TION+wrap+heater
wrap+heater
Relative(95% CI)
Absolute
TEMPERATURE<36.0°C
4Observa-
tionalserious serious serious serious none
361/4845 (7.45%)
736/4489
(16.39%)
OR = 0.40 (0.35-0.46)
90 fewer per 1000[from 110 fewer to 80
fewer]
ÅÅOOLOW
CRITICAL
TEMPERATURE>38.0°C
3Observa-
tionalserious serious serious Serious none
91/4562 (1.99%)
78/4423 (1.76%)
OR = 1.12(0.82-1.52)
0 more per 1000[from 0 fewer to 10 more]
ÅÅOOLOW
IMPORTANT
Dallas 2015Proposed Consensus on Science statements
THERMAL MATTRESS + PLASTIC WRAP + RADIANT WARMER (I) Vs PLASTIC WRAP + RADIANT WARMER (C).
For the critical outcome of “hypothermia (<36.0oC) at NICU admission” we have identified low quality evidence (downgraded for serious risk of bias) from one RCT (McCarthy, 2013, e135) enrolling 72 preterm infants <32 weeks gestation showing no benefit (RR 1.89 95% CI 0.18-19.95), and 4 observational studies (Billimoria, 2013, 455; Chawla, 2011, 780; Ibrahim, 2010, 795; Singh, 2010, 45) including 612 patients <32 weeks gestation showing benefit (OR 0.27 95% CI 0.18- 0.42).
For the important outcome of “hyperthermia (>38.0oC) at admission” we have identified low quality evidence (downgraded for serious risk of bias) from the same RCT and 4 observational studies (Billimoria, 2013, 455; Chawla, 2011, 780; McCarthy, 2011, 1534; Singh 2010, 45) including 426 patients showing no harm (RR 3.78 95% CI 0.86-16.60 and OR 6.53 95% CI 0.80-53.30, respectively).
Dallas 2015Proposed Consensus on Science statements
ENVIRONMENTAL TEMPERATURE >=26°C + PLASTIC WRAP + RADIANT WARMER (I) Vs PLASTIC WRAP + RADIANT WARMER (C).
For the critical outcome of “hypothermia (<36.0oC) at NICU admission” we have not identified any study addressing this intervention alone.
For the important outcome of “hyperthermia (>38.0oC) at admission” we have identified low quality evidence (downgraded for serious risk of bias) from one observational study (Knobel, 2005, 304) including 40 patients <29 weeks gestation showing no harm (OR 8.45 95% CI 0.37-182.58). HEATED AND HUMIDIFIED GASES + PLASTIC WRAP + RADIANT WARMER (I) Vs PLASTIC WRAP + RADIANT WARMER (C).
For the critical outcome of “hypothermia (<36.0oC) at NICU admission” we have identified low quality evidence (downgraded for serious risk of bias) from one RCT (Meyer, 2014, epub ahead of print) enrolling 203 patients <32 weeks gestation showing no benefit (RR 0.64 95% CI 0.31-1.35), and one observational study (Te Pas, 2010, e1427) including 112 patients <33 weeks gestation showing benefit (OR 0.20 95% CI 0.08-0.47).
For the important outcome of “hyperthermia (>38.0oC) at admission” we have identified low quality evidence (downgraded for serious risk of bias) from the same observational study showing no harm (OR not estimable).
Dallas 2015Proposed Consensus on Science statements
PLASTIC CAP + WRAP + RADIANT WARMER (I) Vs PLASTIC WRAP + RADIANT WARMER (C).
For the critical outcome of “hypothermia (<36.0oC) at NICU admission” we have identified low quality evidence (downgraded for serious risk of bias) from one RCT (Doglioni, 2014, 261) enrolling 100 patients <29 weeks gestation showing no benefit (RR 0.60 95% CI 0.24-1.53).
For the important outcome of “hyperthermia (>38.0oC) at admission” we have identified low quality evidence (downgraded for serious risk of bias) from the same RCT showing no harm (RR 0.33 95% CI 0.01-7.99). COMBINATION OF INTERVENTIONS (ENVIRONMENTAL TEMPERATURE 23-25°C + RADIANT WARMER + WRAP BODY AND HEAD IN PLASTIC WITHOUT DRYING + CAP + THERMAL MATTRESS) Vs RADIANT WARMER + PLASTIC WRAP.
For the critical outcome of “hypothermia (<36.0oC) at admission” we have identified low quality evidence (downgraded for serious risk of bias) from 4 observational studies (deMauro, 2013, e1018; Lee, 2014, e1378; Pinheiro, 2014, e218; Russo 2014, e1) enrolling 9334 patients <35 weeks gestation showing benefit (OR 0.40 95% CI 0.35-0.46).
For the important outcome of “hyperthermia (>38.0oC) 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 (OR 1.12 95% CI 0.82-1.52).
Dallas 2015Draft Treatment Recommendations
Among newly born preterm infants <32 weeks gestation under radiant warmers in the hospital delivery room, we recommend using a combination of interventions (environmental temperature 23-25oC, warm blankets, plastic body and head wrapping without drying, cap, thermal mattress) to reduce hypothermia (<36.0oC) on admission at NICU (strong recommendation, moderate quality of evidence). Values and preferences statement: in making this recommendation we also place a value on avoiding hyperthermia (>38.0oC) during application of all above interventions.
Dallas 2015Knowledge Gaps
Although a combination of interventions (increasing environmental temperature, warm blankets, thermal mattress, and cap) linked to quality improvement initiatives, are effective in reducing hypothermia (<36oC) on NICU admission among newly born preterm infants <32 weeks gestation who are under radiant warmers and plastic wrap, the contribution of each intervention (increasing environmental temperature, thermal mattress, heated and humidified gases, and cap) remains to be established.
Dallas 2015Next Steps
This slide will be completed during Task Force Discussion (not EvRev) and should include:
Consideration of interim statementPerson responsibleDue date