1. Dallas 2015 TFQO: S. Velaphi COI #242 EVREVs: N. Singhal COI#213 H. Ersdal COI#76 Taskforce: Neonatal Maintaining Infant Temperature During Delivery Room Resuscitation Unique PICO ID# NRP 793

2. Dallas 2015 COI Disclosure EVREV 1 Velaphi COI#242 None EVREV 2 Singhal COI#213 None EVREV 3 Ersdal COI#76 None

3. Dallas 2015 2010 Treatment Recommendation Topic not reviewed in 2010

4. Dallas 2015 Search 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])

5. Dallas 2015 Inclusion/Exclusion & Articles Found Number retrieved 1517 Pubmed – 906; Embase – 609; Cochrane- 2 Inclusions Criteria Human newborns >30 weeks GA, English papers Exclusion Criteria Newborns <30 weeks GA, non-English papers, non-RCT Number Finally Included in Evidence Profile tables RCTs # 11 Excluded # 1831

6. Dallas 2015 C2015 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 bag Comparison: Drying and no skin to skin or use of radiant warmer or isolette Outcomes: change body temperature (8- important)

7. 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.

8. Dallas 2015 2015 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.

9. Dallas 2015 Risk of Bias in studies: SSC RCT bias assessment StudyYearDesign Total Patients Population Industry Funding Allocation: Generation Allocation: Concealment Blinding: Participants Blinding: Assessors Outcome: Complete Outcome: Selective Other Bias Bergman 2004RCT31 Preterm vigorous, CapeTownNoLow HighLow Bytrova 2003RCT132Term, RussiaNoUnclearLowHighUnclearLow Christensson 1992RCT50 Term vigorous, SwedenNoUnclearHigh UnclearLow Christensson 1996RCT30Term, SwedenUnclearHigh UnclearLow Fardig 1980RCT51Term vigorous, USANoUnclearLowHighUnclearLow Gabriel 2010RCT23835-40w, SpainNoHigh UnclearLow Gouchon 2010RCT34Term vigorous, ItalyNoLow HighUnclearLow Nimbalkar 2014RCT100>1800, IndiaNoLow HighUnclearLow

10. Dallas 2015 Risk of Bias in studies: Plastic Bags RCT bias assessment StudyYearDesign Total Patients Population Industry Funding Allocation: Generation Allocation: Concealment Blinding: Participants Blinding: Assessors Outcome: Complete Outcome: Selective Other Bias Belsches 2013RCT271Term vigorous, ZambiaNoLow High Low Leadford 2013RCT104Preterm, ZambiaNoLow High Low Raman 1994RCT104Term, MalaysiaNoHigh Low

11. Dallas 2015 Evidence profile table: Skin to skin contact vs Cot or Open Crib and Swaddling with or without initial use of warmer Quality assessment№ of patientsEffect QualityImportance № of studies Study design Risk of biasInconsistencyIndirectnessImprecision Other considerations Skin 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 7randomised trials serious 1 not seriousserious 2 serious 3 nonenot estimable ⨁ ◯◯◯ VERY LOW

12. Dallas 2015 Evidence profile table: Skin to skin contact vs Incubator or Isolette Quality assessment№ of patientsEffect QualityImportance № of studies Study design Risk of bias Inconsiste ncy Indirectnes s Imprecisio n 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 2randomised trials very serious 1 not serious serious 2 3 nonenot estimable ⨁ ◯◯◯ VERY LOW

13. Dallas 2015 Evidence profile table Plastic Bag with or without drying and Swaddling vs Cot or Open Crib with or without initial use of radiant warmer Quality assessment№ of patientsEffect QualityImportance № of studies Study design Risk of bias InconsistencyIndirectnessImprecision Other considerations Plastic Bag with or without drying and Swaddling Cot or open crib with or without radiant warmer Relative (95% CI) Absolute (95% CI) Maintaining body temperature or avoiding hypothermia 3randomised trials serious 2 serious 1 not seriousserious 1 3 nonenot estimable ⨁ ◯◯◯ VERY LOW

14. Dallas 2015 Key data SSC Five RCTs: SSC versus incubator, heated crib, standard care SSC versus cot and standard care (wrapped, under warmer)

15. Dallas 2015 Key data Plastic cover Two RCTs Plastic Bag versus WHO standard care (wrapping, isolette, or warmer)

16. 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

17. 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.

18. 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 bags During 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

19. Dallas 2015 2015 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.

20. Dallas 2015 2015 Proposed Treatment Recommendation: Plastic Bag There 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.

21. Dallas 2015 Knowledge Gaps Plastic bags: Infants requiring resuscitation Using a plastic with or without drying during resuscitation Plastic bag versus cover SSC: Infants requiring resuscitation Duration of skin to skin Care of baby skin to skin and other methods of warming

22. Dallas 2015 Next Steps This slide will be completed during Task Force Discussion (not EvRev) and should include: Consideration of interim statement Person responsible Due date