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Dallas 2015 TFQO: Marilyn Escobedo COI#78 EVREV 1: Marilyn Escobedo COI#78 EVREV 2: Henry Lee COI#135 Taskforce: NRP Babies born to mothers who are hypothermic.

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Presentation on theme: "Dallas 2015 TFQO: Marilyn Escobedo COI#78 EVREV 1: Marilyn Escobedo COI#78 EVREV 2: Henry Lee COI#135 Taskforce: NRP Babies born to mothers who are hypothermic."— Presentation transcript:

1 Dallas 2015 TFQO: Marilyn Escobedo COI#78 EVREV 1: Marilyn Escobedo COI#78 EVREV 2: Henry Lee COI#135 Taskforce: NRP Babies born to mothers who are hypothermic or hyperthermic in labor NRP 804

2 Dallas 2015 COI Disclosure EVREV 1 COI# 78 Escobedo Commercial/industry None Potential intellectual conflicts None EVREV 2 COI#135 Lee Commercial/industry None Potential intellectual conflicts None

3 Dallas 2015 2010 CoSTR No review in 2010.

4 Dallas 2015 C2015 PICO Population: Newborn babies Intervention: Maternal hypothermia or hyperthermia in labor Comparison: Normal maternal temperature Outcomes: Adverse neonatal effects 9-Critical Mortality 6-Important Adverse neurological outcome 6-Important Incidence of seizures

5 Dallas 2015 Inclusion/Exclusion & Articles Found Inclusions RCTs, studies with concurrent or historical controls Exclusions Reviews, animal studies, unpublished studies, abstracts 1426 Number of Articles initially identified, and 22 Finally Included in Evidence Profile tables 7 RCTs, 15 non-RCTs Remainder excluded

6 Dallas 2015 2015 Proposed Treatment Recommendations With regard to maternal hyperthermia Although maternal hyperthermia is associated with adverse neonatal outcomes, there is insufficient evidence to make a recommendation on the management of maternal hyperthermia. With regard to maternal hypothermia There is insufficient evidence to make a recommendation about maternal hypothermia. There are no randomized controlled trials of important or critical neonatal outcomes after interventions to keep mothers normothermic.

7 Dallas 2015 Risk of Bias in studies

8 Dallas 2015 Risk of Bias in studies

9 Dallas 2015 Key data from key studies

10 Dallas 2015 Key data from key studies

11 Dallas 2015 Evidence profile table(s)

12 Dallas 2015 Proposed Consensus on Science statements Maternal Hyperthermia For the critical outcome of mortality we have identified low quality evidence from 2 non-RCT studies showing an increased risk with maternal hyperthermia (Petrova 2001, 20, Alexander 1999, 274) For the important outcome of neonatal seizures we have identified low quality evidence from 7 non RCT studies showing an increased risk with maternal hyperthermia (Alexander 1999, 274, Greenwell 2012, e447, Petrova 2001, 20, Goetzel 2010, 363.e1, Glass 2009, 24, Lieberman 2000, 8, Lieberman 2000, 983) For the important outcome of other adverse neurological states (encephalopathy) we have identified low quality evidence from 4 non- RCT studies showing an increased risk with maternal hyperthermia (Badawi 1998, 1554, Impey 2001 49.e1, Impey 2008, 594, Linder 2013, 207)

13 Dallas 2015 Proposed Consensus on Science statements Maternal hypothermia For the critical outcome of mortality and the important outcomes of seizures or adverse neurologic states (encephalopathy) we have identified very low quality evidence from 5 RCTs that showed no significant risk of these outcomes with maternal hypothermia (Butwick 2007, 1413, Fallis 2002, 324, Horn 2002, 409, Woolnough 2009, 346, Yokohama 2009, 242). However, these studies did not examine the outcomes of mortality, seizures, or adverse neurologic outcome.

14 Dallas 2015 2015 Proposed Treatment Recommendations With regard to maternal hyperthermia Although maternal hyperthermia is associated with adverse neonatal outcomes, there is insufficient evidence to make a recommendation on the management of maternal hyperthermia. With regard to maternal hypothermia There is insufficient evidence to make a recommendation about maternal hypothermia. There are no randomized controlled trials of important or critical neonatal outcomes after interventions to keep mothers normothermic.

15 Dallas 2015 Values & Preferences Although maternal hyperthermia is associated with adverse neonatal outcomes, it remains unclear if interventions to normalize maternal temperature would change those outcomes. Suggesting avoidance of abnormal maternal temperature places value on the possibility of reducing harm.

16 Dallas 2015 Knowledge Gaps Do interventions to achieve normothermia in mothers who are hyperthermic decrease risk of adverse outcomes for newborns? (Lack of RCTs) Do interventions to achieve normothermia in mothers who are hypothermic decrease risk of adverse outcomes for newborns? (Lack of critical / important outcomes)

17 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 Essential slide (one slide only). Estimated time <30 sec


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