Dallas 2015 TFQO: S. Velaphi COI #242 EVREVs: N. Singhal COI#213 H. Ersdal COI#76 Taskforce: Neonatal Maintaining Infant Temperature During Delivery Room.

Dallas 2015

TFQO: S. Velaphi COI #242EVREVs: N. Singhal COI#213

H. Ersdal COI#76Taskforce: Neonatal

Maintaining Infant Temperature During Delivery Room Resuscitation

Unique PICO ID# NRP 793

Dallas 2015

COI Disclosure

EVREV 1 Velaphi COI#242 None

EVREV 2 Singhal COI#213None

EVREV 3 Ersdal COI#76None

Dallas 2015

2010 Treatment Recommendation

Topic not reviewed in 2010

Dallas 2015Search Strategy

("Hypothermia"[Mesh] OR hypothermi*[TIAB] OR "Body Temperature"[Mesh:NoExp] OR "Body Temperature Regulation"[Mesh:NoExp] OR Normothermia[TIAB]) AND (exothermic[TIAB] OR transwarmer[TIAB] OR heat*[TIAB] OR Warm*[TIAB] OR "Rewarming"[Mesh] OR “re-warm”[TIAB] OR "Incubators, Infant"[Mesh] OR Incubat*[TIAB] OR “radiant warmer”[TIAB] OR “radiant warmers”[TIAB] OR wrap*[TIAB] OR “isolation bag”[TIAB] OR “isolation bags”[TIAB]OR "Plastics"[Mesh] OR “skin to skin”[TIAB] OR “skin-to-skin”[TIAB] OR "Hyperthermia, Induced"[Mesh] OR "Hot Temperature/therapeutic use"[Mesh] OR "Kangaroo-Mother Care Method"[Mesh] OR “kangaroo-mother”[TIAB] OR “kangaroo mother”[TIAB] OR “kangaroo care”) AND ("Infant, Newborn"[Mesh] OR Infant*[TIAB] OR Neonat*[TIAB] OR Newborn*[TIAB] OR "Delivery Rooms"[Mesh] OR "Gestational Age"[Mesh] OR "Premature Birth"[Mesh] OR "Term Birth"[Mesh] OR "Live Birth"[Mesh] OR "Birthing Centers"[Mesh] OR "Neonatal Nursing"[Mesh] OR "Intensive Care, Neonatal"[Mesh] OR "Intensive Care Units, Neonatal"[Mesh] OR "Low Birth Weight"[TIAB] OR "Small for Gestational Age"[TIAB] OR prematur*[TIAB] OR preterm[TIAB])NOT (animals[Mesh] NOT humans[Mesh]) NOT ("letter"[Publication Type] OR "comment"[Publication Type] OR "editorial"[Publication Type] or Case Reports[Publication Type])

Dallas 2015

Inclusion/Exclusion & Articles FoundNumber retrieved 1517

Pubmed – 906; Embase – 609; Cochrane- 2

Inclusions CriteriaHuman newborns >30 weeks GA, English papers

Exclusion CriteriaNewborns <30 weeks GA, non-English papers, non-RCT

Number Finally Included in Evidence Profile tables

RCTs # 11Excluded # 1831

Dallas 2015C2015 PICO

Population: In low-resource settings, in newborn infants (>30 weeks gestation) during and/or post resuscitation/ stabilization Intervention: Drying and skin to skin contact or plastic bagComparison: Drying and no skin to skin or use of radiant warmer or isoletteOutcomes: change body temperature (8-important)

Dallas 2015

2015 Proposed Treatment Recommendation: Plastic

Bag

There is limited data during resuscitation/stabilization.In order to maintain body temperature or avoid hypothermia during transition (first 1-2 hours of life), we suggest that after a newborn infant >30 weeks gestation has been dried, he/she may be put in a plastic bag and swaddled (weak recommendation, very low quality of evidence) compared to open crib or cot. Values, preferences and costs for Plastic cover

In making this suggestion we considered the decrease in hypothermia with plastic. However clean plastic may not be available and costly and use of unclean plastic may lead to infections.

Dallas 20152015 Proposed

Treatment Recommendation: Skin to Skin

There is no data on skin to skin during resuscitation/ stabilization. During transition (1-2 hours after birth), we suggest to nurse newborns >30 weeks gestation with skin to skin contact or kangaroo mother care compared to cot/ open crib or incubator (weak recommendation, very low quality of evidence). Values, preferences and costs for skin to skin contact

In making this suggestion we valued the prevention of hypothermia using a free and effective intervention.

Dallas 2015

Risk of Bias in studies: SSC

RCT bias assessment

Study Year Design Total Patients Population Industry

Funding

Allocation:

Generation

Allocation:

Concealment

Blinding: Participa

nts

Blinding: Assessor

s

Outcome:

Complete

Outcome:

SelectiveOther Bias

Bergman 2004 RCT 31Preterm vigorous,

CapeTown No Low Low High Low Low Low LowBytrova 2003 RCT 132 Term, Russia No Unclear Low High Unclear Low Low Low

Christensson 1992 RCT 50Term vigorous,

Sweden No Unclear High High Unclear Low Low LowChristensson 1996 RCT 30 Term, Sweden Unclear High High Unclear Low Low Low

Fardig 1980 RCT 51 Term vigorous, USA No Unclear Low High Unclear Low Low LowGabriel 2010 RCT 238 35-40w, Spain No High High High Unclear Low Low Low

Gouchon 2010 RCT 34 Term vigorous, Italy No Low Low High Unclear Low Low LowNimbalkar 2014 RCT 100 >1800, India No Low Low High Unclear Low Low Low

Dallas 2015

Risk of Bias in studies: Plastic Bags

RCT bias assessment

Study Year Design Total Patients Population Industry

Funding

Allocation:

Generation

Allocation:

Concealment

Blinding: Participa

nts

Blinding: Assessor

s

Outcome:

Complete

Outcome:

SelectiveOther Bias

Belsches 2013 RCT 271 Term vigorous, Zambia No Low Low High High Low Low LowLeadford 2013 RCT 104 Preterm, Zambia No Low Low High High Low Low LowRaman 1994 RCT 104 Term, Malaysia No High High High High Low Low Low

Dallas 2015Evidence profile table:

Skin to skin contact vs Cot or Open Crib and Swaddling with or without initial use of

warmerQuality assessment № of patients Effect

Quality Importance№ of studies

Study design Risk of bias Inconsistency Indirectness Imprecision Other

considerationsSkin to skin contact or

kangaroo care

Cot or open crib and Swaddling with or without

initial use of radiant warmer

Relative(95% CI)

Absolute(95% CI)

Maintenance of temperature or preventing hypothermia

7 randomised trials

serious 1 not serious serious 2 serious 3 none not estimable

not estimable ⨁◯◯◯

VERY LOW

Dallas 2015

Evidence profile table: Skin to skin contact vs Incubator or Isolette

Quality assessment № of patients Effect

Quality Importance№ of studies

Study design

Risk of bias

Inconsistency

Indirectness

Imprecision

Other considerati

ons

Skin to skin

contact or kangaroo

care

Incubator or Isolette

Relative(95% CI)

Absolute(95% CI)

Maintenance of body temperature or preventing hypothermia

2 randomised trials

very serious 1

not serious not serious serious 2 3 none not estimable not estimable ⨁◯◯

◯VERY LOW

Dallas 2015

Evidence profile tablePlastic Bag with or without drying and Swaddling vs Cot or Open Crib with or without initial use of radiant warmer

Quality assessment № of patients Effect

Quality Importance№ of

studies Study design Risk of bias Inconsistency Indirectness Imprecision Other

considerationsPlastic Bag with or without drying and

SwaddlingCot or open crib with or without radiant warmer

Relative(95% CI)

Absolute(95% CI)

Maintaining body temperature or avoiding hypothermia

3 randomised trials

serious 2 serious 1 not serious serious 1 3 none not estimable

not estimable ⨁◯◯◯

VERY LOW

Dallas 2015

Key data SSCFive RCTs:

SSC versus incubator, heated crib, standard care

SSC versus cot and standard care (wrapped, under warmer)

Dallas 2015Key data Plastic cover

Two RCTs Plastic Bag versus WHO standard care (wrapping, isolette, or warmer)

Dallas 2015

Consensus on Science statements: SSC vs Cot or Crib with or without initial use of radiant warmer

During transition (birth to 1-2 hours after birth), we have identified very low quality evidence (downgraded for risk of bias, indirectness and imprecision) from 7 RCTs (Fardig 1980, 19; Christensson 1992, 488; Christensson 1996, 1354; Boytrova 2003, 320; Gouchon 2010, 78; Gabriel 2010, 1630; Nimbalkar 2014, 364) enrolling 600 newborns >30 weeks gestation showing reduction in a number of babies with hypothermia when nursed with SSC post-delivery (Fardig 1980, 19; Christensson 1996, 1354; Boytrova 2003, 320; Nimbalkar 2014, 364) or similar body temperatures (Christensson 1992, 488; Gouchon 2010, 78; Gabriel 2010, 1630) when compared to cot or crib and swaddling with or without initial use of radiant warmer

Dallas 2015

Consensus on Science statements: SSC vs Isolette

For the important outcome “normothermia or preventing hypothermia” during resuscitation we could not find any studies reporting on SSC. During transition (birth to 1-2 hours after delivery), we have identified very low quality evidence (downgraded for risk of bias, indirectness and imprecision) from 2 RCTs (Bergman 2004, e779; Christensson 1996, 1354) enrolling 66 newborns >30 weeks gestation showing reduction in incidence of hypothermia by about 90% (Bergman 2004, e779) or a 50% reduction in drop in body temperature (Christensson 1996, 1354) with skin to skin contact compared to incubator isolette.

Dallas 2015

Consensus on Science statements: Plastic bags with or without skin drying and swaddling compared to cot or crib with or without initial use of radiant warmer

For the important outcome “normothermia or preventing hypothermia” during resuscitation, we could not find any studies reporting on plastic bagsDuring transition (from birth to 1-2 hours after delivery), we have identified very low quality evidence (downgraded for risk of bias, inconsistency and imprecision) from 3 RCTs (Belsches 2013, e656; Leadford 2013, e128; Raman 1992, 117) enrolling 409 newborns >30 weeks gestation, showing either a reduction in incidence of hypothermia with plastic after drying (Belsches 2013, e656; Leadford 2013, e128), RR-0.77 (95% CI, 0.65-0.90) or no difference in temperature (Raman 1992, 117) with plastic with or without drying compared to cot bed or open crib and swaddling with or without initial use of radiant warmer

Dallas 20152015 Proposed

Treatment Recommendation: Skin to Skin

There is no data on skin to skin during resuscitation/ stabilization. In order to maintain normal body temperature or prevent hypothermia during transition (birth to 1-2 hours after birth), we suggest to nurse well newborns >30 weeks gestation with skin to skin contact or kangaroo mother care compared to cot/ open crib and swaddling or incubator (weak recommendation, very low quality of evidence). Values, preferences and costs for skin to skin contact

In making this suggestion we valued the prevention of hypothermia using a free and effective intervention.

Dallas 2015

2015 Proposed Treatment Recommendation: Plastic

BagThere is not data during resuscitation/stabilization.In order to maintain body temperature or prevent hypothermia during transition (birth to 1-2 hours of life), we suggest that after a well newborn infant >30 weeks gestation has been dried, he/she may be put in a plastic bag and swaddled (weak recommendation, very low quality of evidence) compared to open crib or cot and swaddling. Values, preferences and costs for Plastic cover

In making this suggestion we considered the decrease in hypothermia with plastic. However clean plastic may not be available and costly and use of unclean plastic may lead to infections.

Dallas 2015

Knowledge Gaps

Plastic bags:Infants requiring resuscitationUsing a plastic with or without drying during resuscitationPlastic bag versus cover

SSC:Infants requiring resuscitationDuration of skin to skinCare of baby skin to skin and other methods of warming

Dallas 2015Next Steps

This slide will be completed during Task Force Discussion (not EvRev) and should include:

Consideration of interim statementPerson responsibleDue date