Conflict of Interest Declaration
The ILCOR Continuous Evidence Evaluation process is guided by a rigorous ILCOR Conflict of Interest policy. The following Task Force members and other authors were recused from the discussion as they declared a conflict of interest: None.
The following Task Force members and other authors declared an intellectual conflict of interest and this was acknowledged and managed by the Task Force Chairs and Conflict of Interest committees. Two authors (PGD and GMS) were co-authors of one of the included RCTs. They were excluded from rating their own paper.
CoSTR Citation
Trevisanuto D, Roehr CC, Davis PG, Schmölzer GM, Wyckoff MH, Rabi Y, de Almeida MF, El-Naggar W, Fabres JG, Fawke J, Foglia EE, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kawakami M, Kim HS, Liley HG, McKinlay CJD, Perlman JM, Sugiura T, Wyllie JP, Weiner GM. Devices for administering PPV at birth (NLS#870 [Internet] Brussels, Belgium. International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force, February 15, 2021. Available from http://ilcor.org
Methodological Preamble (and Link to Published Systematic Review)
The continuous evidence process for the creation of Consensus of Science and Treatment Recommendations (CoSTR) started with a scoping review of devices for administering positive pressure ventilation at birth and was conducted by the Neonatal Task Force members. {Roehr CC 2020 DOI: 10.1038/s41390-020-1005-4} This scoping review identified sufficient new evidence to justify conducting a new systematic review and reconsideration of current resuscitation guidelines. The resulting consensus on science was considered when formulating the Treatment Recommendations.
Systematic Review
Trevisanuto D, Roehr CC, Davis PG, Schmölzer G, Wyckoff MH, Liley HG, Yacov Rabi Y, Weiner GM for the International Liaison Committee On Resuscitation Neonatal Life Support Task Force. Devices for Administering Ventilation at birth: A Meta-analysis. Pediatrics. Submitted 1/17/2021
Devices for administering PPV at birth (NLS#) PICOST
The PICOST
(Population, Intervention, Comparator, Outcome, Study Designs, and Time Frame)
Population: Newborns receiving ventilation (PPV) during resuscitation.
|
Comparisons |
Interventions: |
Comparators: |
|
1 2 3 4 |
T-piece resuscitator T-piece resuscitator Flow-inflating bag Self-inflating bag with PEEP valve |
Self-inflating bag Flow-inflating-bag Self-inflating bag Self-inflating bag without PEEP valve |
Outcomes:
Selecting outcomes
The choices of outcomes using the GRADE classifications of critical or important were debated by the Task Force and were based on a consensus outcome rating for international neonatal resuscitation guidelines (range 1-3 low importance for decision-making, 4-6 important but not critical for decision-making, 7-9 critical for decision-making). {Strand 2020 328} Potential sub-groups were defined a priori. Outcomes were converted into primary and secondary outcomes for submission to PROSPERO.
Outcomes listed in the systematic review:
Primary outcome
- In-hospital mortality (critical 9)
Secondary outcomes
- Severe intraventricular hemorrhage, Papile grade III-IV (critical 8)
- Intraventricular hemorrhage (any) (important 6)
- Bronchopulmonary dysplasia (critical 7)
- CPR or medications in delivery room (critical 7)
- Air leak (important 6)
- Intubation in delivery room (important 6)
- Duration of PPV in delivery room (important 5)
- Length of stay (important 5)
- Admission to NICU (important 4)
A priori subgroups
- Gestational age: a) full term infants; b) preterm infants 28+0 to 36+6 weeks’ gestation; c) preterm infants < 28+0 weeks’ gestation
- Use of self-inflating bag with vs without PEEP valve (each compared with T-piece resuscitator)
Study Designs: Randomized controlled trials (RCTs) and non-randomized studies (non-randomized controlled trials, interrupted time series, controlled before-and-after studies, cohort studies) were eligible for inclusion. Unpublished studies (e.g., conference abstracts, trial protocols) were excluded.
Timeframe: All years and all languages were included as long as there was an English abstract; unpublished studies (e.g., conference abstracts, trial protocols) were excluded. Literature search updated to 30th December 2020.
PROSPERO registration:
The review was registered with PROSPERO [CRD42020200331].
Risk of Bias:
Overall, study-level risk of bias was high or unclear. All studies were at high risk of bias for lack of blinding of participants and personnel due to the nature of the intervention and were at unclear risk of bias for blinding of outcome assessors. Most studies had unclear allocation concealment. One study had high risk of selective reporting, due to a lack of a prospectively registered protocol and inadequate reporting.
Most outcomes selected for GRADE assessment were rated as very low or low certainty evidence. This uncertainty was attributable for most outcomes not only to high risk of bias but also to serious inconsistency, indirectness and (due to low event rates) imprecision.
Consensus on Science
COMPARISON 1: T-PIECE RESUSCITATOR COMPARED TO SELF-INFLATING BAG (with or without PEEP valve).
The systematic review identified 4 RCTs {Dawson 2011 912; Kookna 2019 66; Szyld 2014 165; Thakur 2015 21} involving 1247 neonates and 1 prospective cohort study {Guinsburg 2018 F49} involving 1962 neonates.
For the critical outcome of in-hospital mortality, the evidence of very low certainty (downgraded for serious risk of bias, indirectness and imprecision) from 4 trials involving 1247 infants {Dawson 2011 912; Kookna 2019 66; Szyld 2014 165; Thakur 2015 21} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (risk ratio (RR) 0.74; 95% confidence interval (CI) 0.40 to 1.34; P = 0.31; Absolute Risk Difference [ARD], 10 fewer patients/1000 die when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 23 fewer patients/1000 to 13 more patients/1000 die when receiving positive pressure ventilation with a T-piece resuscitator]).
For the critical outcome of in-hospital mortality, the evidence of very low certainty from 1 prospective cohort study involving 1962 preterm infants {Guinsburg 2018 F49} showed benefit from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 0.71; 95% CI 0.63 to 0.80; P <0.001; ARD -12.8%; 95% CI -16.4% to -8.9%; NNT = 8).
For the critical outcome of bronchopulmonary dysplasia, the evidence of very low certainty (downgraded for serious risk of bias, inconsistency and indirectness) from 4 trials involving 1247 infants {Dawson 2011 912; Kookna 2019 66; Szyld 2014 165; Thakur 2015 21} showed benefit from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 0.64, 95% CI 0.43 to 0.95; P = 0.03; ARD -3.2%; 95% CI -5.1% to -0.4; NNT = 32.
For the critical outcome of bronchopulmonary dysplasia, the evidence of very low certainty from 1 prospective cohort study involving 1327 preterm infants {Guinsburg 2018 F49 } showed benefit from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR, 0.79, 95% CI, 0.65 to 0.96; P = 0.02; ARD -6.6%; 95% CI -11.0% to -1.3%; NNT = 15).
For the critical outcome of severe intraventricular hemorrhage (grade III-IV), the evidence of very low certainty from 1 prospective cohort study involving 1594 preterm infants {Guinsburg 2018 F49} showed benefit from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 0.75, 95% CI 0.57 to 0.98; P = 0.04; ARD -4.0%; 95% CI -6.9% to -0.3%; NNT = 24).
For the critical outcome of cardio-pulmonary resuscitation or medications in the delivery room, the evidence of very low certainty (downgraded for serious risk of bias, indirectness and imprecision) from 4 trials involving 1247 infants {Dawson 2011 912; Kookna 2019 66; Szyld 2014 165; Thakur 2015 21} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 0.58, 95% CI 0.28 to 1.23; P = 0.16; ARD, 12 fewer patients/1000 receive cardio-pulmonary resuscitation or medications in the delivery room when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 21 fewer patients/1000 to 7 more patients/1000 receive cardio-pulmonary resuscitation or medications in the delivery room when receiving positive pressure ventilation with a T-piece resuscitator]).
For the critical outcome of cardio-pulmonary resuscitation or medications in delivery room, the evidence of very low certainty from 1 prospective cohort study involving 1962 preterm infants {Guinsburg 2018 F49} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 0.82, 95% CI 0.60 to 1.12; P = 0.22; ARD, 18 fewer patients/1000 receive cardio-pulmonary resuscitation or medications in the delivery room when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 40 fewer patients/1000 to 12 more patients/1000 receive cardio-pulmonary resuscitation or medications in the delivery room when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of intraventricular hemorrhage (all grades) and the critical outcome of severe intraventricular hemorrhage (grade III-IV), unpublished data obtained from the author of one small RCT {Thakur 2015 21} and from the author of a cluster RCT {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag. However, the lack of adjustment for center and risk of ascertainment bias culminated in such extremely low certainty in these results that the data are not presented.
For the important outcome of intraventricular hemorrhage (all grades), the evidence of very low certainty from 1 prospective cohort study involving 1594 preterm infants {Guinsburg 2018 F49} showed benefit from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 0.72, 95% CI 0.63 to 0.83; P < 0.001; ARD -12.9%; 95% CI -17% to -7.8%, NNT = 8).
For the important outcome of air leak, the evidence of very low certainty (downgraded for serious risk of bias and imprecision) from 4 trials involving 1247 infants {Dawson 2011 912; Kookna 2019 66; Szyld 2014 165; Thakur 2015 21} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 1.29, 95% CI 0.60 to 2.77; P = 0.52; ARD 5 more patients/1000 with air leak when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 7 fewer patients/1000 to 31 more patients/1000 with air leak when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of air leak, the evidence of very low certainty from 1 prospective cohort study involving 1962 preterm infants {Guinsburg 2018 F49} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 1.23, 95% CI 0.82 to 1.85; P = 0.32; ARD 13 more patients/1000 with air leak when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 10 fewer patients/1000 to 47 more patients/1000 with air leak when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of duration of positive pressure ventilation in the delivery room, the evidence of moderate certainty (downgraded for serious risk of bias) from 3 trials involving 1098 infants {Kookna 2019 66; Szyld 2014 165; Thakur 2015 21} showed benefit from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (Mean Difference (MD) -19.8 seconds; 95% CI -27.7 to -12.0 seconds; P < 0.001).
For the important outcome of intubation in the delivery room, the evidence of very low certainty (downgraded for serious risk of bias, inconsistency and indirectness) from 4 trials involving 1266 infants {Dawson 2011 912; Kookna 2019 66; Szyld 2014 165; Thakur 2015 21} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 0.89, 95% CI 0.76 to 1.05; P = 0.15; ARD, 37 fewer intubated patients/1000 when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 80 fewer patients/1000 to 17 more intubated patients/1000 when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of intubation in the delivery room, the evidence of very low certainty from 1 prospective cohort study involving 1962 preterm infants {Guinsburg 2018 F49} showed benefit from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 0.57, 95% CI 0.46 to 0.70; P < 0.01; ARD -28.9%; 95% CI -36.3% to -20.2%; NNT = 8).
For the important outcome of admission to a neonatal intensive care unit, the evidence of low certainty (downgraded for serious risk of bias and indirectness) from 3 trials involving 1184 infants {Dawson 2011 912; Szyld 2014 165; Thakur 2015 21} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (RR 0.98, 95% CI 0.89 to 1.07; P = 0.60; ARD, 12 fewer patients/1000 admitted to a neonatal intensive care unit when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 65 fewer patients/1000 to 42 more patients/1000 admitted to a neonatal intensive care unit when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of length of hospitalization, the evidence of moderate certainty (downgraded for serious risk of bias) from 2 trials involving 1090 infants {Szyld 2014 165; Thakur 2015 21} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (MD -0.25 days, 95% CI 3.39 days shorter to 2.89 days longer duration of hospitalization; P = 0.88).
For the important outcome of length of hospitalization, the evidence of very low certainty from 1 prospective cohort study involving 1962 preterm infants {Guinsburg 2018 F49} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag (MD -0.00 days, 95% CI -4.15 days shorter to 4.15 days longer duration of hospitalization; P = 1.00).
COMPARISON 2: T-PIECE RESUSCITATOR COMPARED TO FLOW-INFLATING BAG
We did not identify any eligible studies comparing a T-piece resuscitator with a flow-inflating bag.
COMPARISON 3: FLOW-INFLATING BAG COMPARED TO SELF-INFLATING BAG
We did not identify any eligible studies comparing a flow-inflating bag with a self-inflating bag.
COMPARISON 4: SELF-INFLATING BAG WITH PEEP VALVE COMPARED TO SELF-INFLATING BAG WITHOUT PEEP VALVE
The systematic review identified two studies, {Holte 2020 e20200494; Szyld 2014 165} (933 infants).
For the critical outcome of in-hospital mortality, the evidence of very low certainty (downgraded for serious risk of bias, indirectness and imprecision) from 2 trials involving 933 infants {Holte 2020 e20200494; Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a self-inflating bag with PEEP valve compared to a self-inflating bag without PEEP valve (RR 0.99, 95% CI 0.59 to 1.67; P = 0.97; ARD 1 fewer patients/1000 died when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 24 fewer patients/1000 to 39 more patients/1000 died when receiving positive pressure ventilation with a T-piece resuscitator]).
For the critical outcome of bronchopulmonary dysplasia, the evidence of low certainty (downgraded for serious risk of bias and imprecision) from 1 trial involving 516 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a self-inflating bag with PEEP valve compared to a self-inflating bag without PEEP valve (RR 1.03, 95% CI 0.58 to 1.81; P = 0.93; ARD 3 more patients/1000 with bronchopulmonary dysplasia when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 35 fewer patients/1000 to 68 more patients/1000 with bronchopulmonary dysplasia when receiving positive pressure ventilation with a T-piece resuscitator]).
For the critical outcome of cardiopulmonary resuscitation or medications in the delivery room, the evidence of very low certainty (downgraded for serious risk of bias and imprecision) from 1 trial involving 516 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a self-inflating bag with PEEP valve compared to a self-inflating bag without PEEP valve (RR 1.43, 95% CI 0.54 to 3.80; P = 0.48; ARD 11 fewer patients/1000 receive cardio-pulmonary resuscitation or medications in the delivery room when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 12 fewer patients/1000 to 74 more patients/1000 receive cardio-pulmonary resuscitation or medications in the delivery room when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of intraventricular hemorrhage (all grades) and the critical outcome of severe intraventricular hemorrhage (grades III-IV), unpublished data obtained from the author of a cluster RCT {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a self-inflating bag with PEEP valve compared to a self-inflating bag without PEEP valve. However, the lack of adjustment for center and risk of ascertainment bias results in such extremely low certainty in these results that the data are not presented.
For the important outcome of air leak, the evidence of very low certainty (downgraded for serious risk of bias and imprecision) from 1 trial involving 516 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a self-inflating bag with PEEP valve compared to a self-inflating bag without PEEP valve (RR 2.34, 95% CI 0.48 to 11.47; P = 0.30; ARD 12 more patients/1000 with air leak when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 5 fewer patients/1000 to 93 more patients/1000 with air leak when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of duration of positive pressure ventilation in the delivery room, the evidence of very low certainty (downgraded for serious risk of bias, indirectness and imprecision) from 2 trials involving 886 infants {Holte 2020 e20200494; Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a self-inflating bag with PEEP valve compared to a self-inflating bag without PEEP valve (MD -3.8 seconds, 95% CI 29.4 seconds shorter to 21.7 seconds longer duration of positive pressure ventilation; P = 0.77).
For the important outcome of intubation in the delivery room, the evidence of moderate certainty (downgraded for serious risk of bias) from 1 trial involving 516 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a self-inflating bag with PEEP valve compared to a self-inflating bag without PEEP valve (RR, 1.19; 95% CI; 0.88 to 1.61; P = 0.25; ARD 15.1 more patients/1000 intubated in delivery room when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 30 fewer patients/1000 to 151 more patients/1000 intubated in delivery room when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of admission to neonatal intensive care unit, the evidence of very low certainty (downgraded for serious risk of bias, inconsistency, indirectness and imprecision) from 2 trials involving 933 infants {Holte 2020 e20200494; Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a self-inflating bag with PEEP valve compared to a self-inflating bag without PEEP valve (RR 1.12; 95% CI 0.96 to 1.30; P = 0.14; ARD, 47 more patients/1000 admitted to a neonatal intensive care unit when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 16 fewer patients/1000 to 117 more patients/1000 admitted to a neonatal intensive care unit when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of length of hospitalization, the evidence of very low certainty (downgraded for serious risk of bias, inconsistency, indirectness and imprecision) from 2 trials involving 914 infants {Holte 2020 e20200494; Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a self-inflating bag with PEEP valve compared to a self-inflating bag without PEEP valve (MD 0.15 days, 95% CI -0.25 to 0.55 days; P = 0.46).
SUBGROUP COMPARISONS:
A – SUBGROUP ANALYSIS ACCORDING TO GESTATIONAL AGE: A) FULL TERM INFANTS; B) PRETERM INFANTS 28-36 WEEKS’ GESTATION; C) PRETERM INFANTS < 28 WEEKS’ GESTATION
The planned analyses by gestational age subgroups were not feasible due to limited data from the available studies. All 4 RCTs {Dawson 2011 912; Kookna 2019 66; Szyld 2014 165; Thakur 2015 21} (1247 infants) identified for this review included preterm infants but with different gestational age cut-offs, so the planned comparisons were not feasible. One study included only preterm infants (n=80) with gestational age <29 weeks {Dawson 2011 912}; one study included infants with gestational age >26 weeks, but reported results of a sub-group of low birthweight infants (n=195) {Szyld 2014 165}; one study reported data from a subgroup of infants with gestational age < 34 weeks (n=37) {Thakur 2015 21}; and one study included only 7 preterm infants {Kookna 2019 66}.
One prospective cohort study {Guinsburg 2018 F49} (1962 neonates) included only preterm infants with gestational age 23-33 weeks.
B – SUBGROUP ANALYSIS COMPARING T-PIECE RESUSCITATOR WITH SELF-INFLATING BAG WITH OR WITHOUT PEEP VALVE
The systematic review identified 1 RCT {Szyld 2014 165} involving 1027 infants.
T-PIECE RESUSCITATOR vs SELF-INFLATING BAG WITH PEEP VALVE
For the critical outcome of in-hospital mortality, the evidence of low certainty (downgraded for serious risk of bias and imprecision) from 1 trial involving 575 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag with PEEP valve (RR 0.51, 95% CI 0.15 to 1.67, P = 0.27; ARD 14 fewer patients/1000 died when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 23 fewer patients/1000 to 18 more patients/1000 died when receiving positive pressure ventilation with a T-piece resuscitator]).
For the critical outcome of bronchopulmonary dysplasia, the evidence of moderate certainty (downgraded for serious risk of bias) from 1 trial involving 575 infants {Szyld 2014 165}
showed benefit from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag with PEEP valve (RR 0.49, 95% CI 0.25 to 0.95; P = 0.04; ARD -4.4%; 95% CI -6.5% to -0.4%; NNT = 23).
For the critical outcome of cardio-pulmonary resuscitation or medications in the delivery room, the evidence of low certainty (downgraded for serious risk of bias and imprecision) from 1 trial involving 575 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag with PEEP (RR 0.56, 95% CI 0.21 to 1.48; P = 0.24; ARD,17 fewer patients/1000 receive cardio-pulmonary resuscitation or medications in the delivery room when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 30 fewer patients/1000 to 18 more patients/1000 receive cardio-pulmonary resuscitation or medications in the delivery room when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of air leak, the evidence of low certainty (downgraded for serious risk of bias and imprecision) from 1 trial involving 575 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag with PEEP valve (RR 1.19, 95% CI 0.40 to 3.49; P = 0.76; ARD 4 more patients/1000 with air leak when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 12 fewer patients/1000 to 52 more patients/1000 with air leak when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of intubation in delivery room, the evidence of moderate certainty (downgraded for serious risk of bias) from 1 trial involving 575 infants {Szyld 2014 165} showed benefit from receiving positive pressure ventilation with a T-piece resuscitator compared a self-inflating bag with PEEP valve (RR 0.69, 95% CI 0.51 to 0.93; P = 0.02; ARD -8.7%; 95% CI -13.7% to -2.0%; NNT 12).
T-PIECE RESUSCITATOR vs SELF-INFLATING BAG WITHOUT PEEP VALVE
For the critical outcome of in-hospital mortality, the evidence of low certainty (downgraded for serious risk of bias and imprecision) from 1 trial involving 452 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag without PEEP valve (RR 1.00, 95% CI 0.36 to 2.80; P = 1.0; ARD 0 fewer patients/1000 died when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 20 fewer patients/1000 to 55 more patients/1000 died when receiving positive pressure ventilation with a T-piece resuscitator]).
For the critical outcome of bronchopulmonary dysplasia, the evidence of moderate certainty (downgraded for serious risk of bias) from 1 trial involving 452 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag without PEEP valve (RR 0.47, 95% CI 0.22 to 1.02; P = 0.06; ARD 45 fewer patients/1000 with BPD when receiving positive pressure ventilation with a T-piece resuscitator, 95% CI 66 fewer to 2 more infants with bronchopulmonary dysplasia per 1000 infants).
For the critical outcome of cardio-pulmonary resuscitation or medications in the delivery room, the evidence of low certainty (downgraded for serious risk of bias and imprecision) from 1 trial involving 452 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag without PEEP valve (RR 0.33, 95% CI 0.07 to 1.63; P = 0.18; ARD 18 fewer patients/1000 receive cardio-pulmonary resuscitation or medications in the delivery room when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 25 fewer patients/1000 to 17 more patients/1000 receive cardio-pulmonary resuscitation or medications in the delivery room when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of air leak, the evidence of low certainty (downgraded for serious risk of bias and imprecision) from 1 trial involving 452 infants {Szyld 2014 165} could not exclude benefit or harm from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag without PEEP valve (RR 3.00, 95% CI 0.61 to 14.71; P = 0.18; ARD 18 more patients/1000 with air leak when receiving positive pressure ventilation with a T-piece resuscitator [95% CI 3 fewer patients/1000 to 121 more patients/1000 with air leak when receiving positive pressure ventilation with a T-piece resuscitator]).
For the important outcome of intubation in the delivery room, the evidence of moderate certainty (downgraded for serious risk of bias) from 1 trial involving 452 infants {Szyld 2014 165} showed benefit from receiving positive pressure ventilation with a T-piece resuscitator compared to a self-inflating bag without PEEP valve (RR 0.58, 95% CI 0.39 to 0.88; P = 0.009; ARD -9.8%; 95% CI -14.3% to -2.8%; NNT = 10).
Treatment Recommendations
COMPARISON 1: T-PIECE RESUSCITATOR vs SELF-INFLATING BAG
Where resources permit, we suggest the use of a T-Piece resuscitator over the use of a self-inflating bag in infants receiving positive pressure ventilation at birth. (Weak recommendation, very low certainty of evidence). A self-inflating bag should be available as a back-up device for the T-piece resuscitator in case of gas supply failure (technical remark).
COMPARISON 2: T-PIECE RESUSCITATOR COMPARED TO FLOW-INFLATING BAG
There are no data to make a treatment recommendation.
COMPARISON 3: FLOW-INFLATING BAG COMPARED TO SELF-INFLATING BAG
There are no data to make a treatment recommendation.
COMPARISON 4: SELF-INFLATING BAG WITH PEEP VALVE COMPARED TO SELF-INFLATING BAG WITHOUT PEEP VALVE
The confidence in effect estimates is so low that the panel feels any recommendation for the use of a PEEP valve with a self-inflating bag versus a self-inflating bag without a PEEP valve is too speculative.
SUBGROUP CONSIDERATIONS
SUBGROUPS ANALYSIS ACCORDING TO GESTATIONAL AGE
There is insufficient data on which to base a recommendation based on gestational age, since the planned sub-group analyses according to gestational age were not feasible.
SUBGROUPS ANALYSIS COMPARING T-PIECE RESUSCITATOR WITH SELF-INFLATING BAG WITH OR WITHOUT PEEP VALVE
Where resources permit, we suggest the use of a T-piece resuscitator over the use of a self-inflating bag either with or without a PEEP valve (Weak recommendation, very low certainty of evidence). However, a self-inflating bag should be available as a backup for the T-piece resuscitator in the event of a gas supply failure (technical remark). For use of self-inflating bag with PEEP valve vs use of self-inflating bag without PEEP valve, the data are too uncertain, so no recommendation can be made.
Justification and Evidence to Decision Framework Highlights
In making these recommendations, the Neonatal Life Support Task Force acknowledges the following:
Because the clinical evidence supporting the use of a T-piece resuscitator is of very low certainty, we have also taken into account the direction of evidence from animal studies showing that PEEP facilitates lung aeration. Animal studies suggest a benefit to using devices providing controlled levels of PEEP and peak inspiratory pressure (PIP) to assist establishment of pulmonary functional residual capacity during transition of a fluid-filled lung to an air-filled lung capable of supporting air-breathing and to reduce lung damage secondary to barotrauma {Bjorklund 1997 348; Haddad 2017 1405; Hillman 2007 575}. Benchtop and manikin studies demonstrate more consistent pressures and tidal volumes when using a T-piece resuscitator than a self-inflating bag {Hawkes 2012 797; Hussey 2004 F490}. However, the certainty of clinical evidence is not sufficient to recommend against using a self-inflating bag during neonatal resuscitation, particularly in regions where pressurized gases are not readily available.
Although subgroup analyses by gestation were not feasible, in contemporary neonatal practice, BPD is mainly an outcome that affects very preterm infants. Therefore, the reduction in the incidence of BPD suggests that use of a T-piece resuscitator may be of greatest benefit for preterm infants.
Knowledge Gaps
There are insufficient studies allowing comparison of benefits and risks of T-piece resuscitators to self-inflating bags by gestational age subgroups. Such studies should include outcomes relevant to each gestational age subgroup (e.g. severe IVH, BPD, neurodevelopmental impairment for very and extremely preterm infants, admission to neonatal intensive or special care unit, receiving subsequent respiratory support, length of hospital stay, air leaks for term and near-term infants).
There are no studies comparing cost-effectiveness of routine use of T-piece resuscitators compared to self-inflating bags.
There are no studies specifically comparing how both T-piece resuscitators and self-inflating bags are used in practice (e.g., pressures delivered, set-up time, ease of use, adjustments to pressures made during use, perceived feedback from the device to the user).
There are no studies comparing how these PPV devices perform using different patient interfaces e.g. facemasks, laryngeal masks, tracheal tubes.
There are no studies comparing the flow-inflating bag to either the T-piece resuscitator or the self-inflating bag (with or without PEEP) for neonatal resuscitation.
There are no clinical trials comparing one T-piece device to another and one self-inflating bag to another, although benchtop experiments demonstrate variations in performance that are of potential clinical importance. The specific devices used in comparative studies should be reported {Hinder 2019 F122; Tracy 2019 F403}.
Attachments
NLS-870-Devices-for-PPV-at-Birth-Et D
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