dallas 2015 tfqo: evrevs: de almeida, maria fernanda coi# trevisanuto, daniele coi# taskforce:...

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

peter morley

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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


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.


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-


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


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.


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-


10/54 (18.51%)

31/58 (53.44%)

OR = 0.20 (0.08-0.47)


fewer]

ÅOOOVERY LOW

CRITICAL

TEMPERATURE>38.0°C

1Observa-


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


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.


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


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.


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-


361/4845 (7.45%)

736/4489

(16.39%)

OR = 0.40 (0.35-0.46)


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).

peter morley

Some topics have very extensive CoS statements, which would take many slides to cover, or would need very small font!


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).

peter morley



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).

peter morley


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

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