Sustained Inflation at Birth (NLS # 809) Systematic Review

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 applicable

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: The following CoSTR authors were co-authors of cited studies; Aziz K, Liley H, Roehr CC, Schmölzer GM, Trevisanuto D, Urlesberger B.

CoSTR Citation

Kapadia VS, K Urlesberger B, Soraisham A, , Rabi Y, Aziz K, Guinsburg R, de Almeida MF, Fabres J, Fawke J, Hosono S, Isayama T, Kim H-S, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Roehr CC, Schmölzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM, Wyckoff MH, Wyllie J. Sustained Inflation at Birth - Consensus of Science with Treatment Recommendations [Internet] Brussels, Belgium: International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force, 2020 February 4. Available from: http://ilcor.org

Methodological Preamble (and Link to Published Systematic Review if applicable)

The continuous evidence process for the production of Consensus on Science with Treatment Recommendations (CoSTR) started with a systematic review of available literature regarding initiating positive pressure ventilation with sustained inflation(s) at birth (http://www.crd.york.ac.uk/PROSPERO/). The literature search was conducted by Mary-Doug Wright, B.Sc., M.L.S. of Apex Information. The Systematic Review was led by Dr. Vishal Kapadia with involvement of clinical content experts Dr. Berndt Urlesberger and Dr. Amuchou Soraisham. Evidence relating to SI neonatal literature was sought and considered by the Neonatal Life Support Task Force. These data were taken into account when formulating the Treatment Recommendations.

PICOST

The PICOST (Population, Intervention, Comparator, Outcome, Study Designs and Timeframe)

Population: For newborn infants who receive positive pressure ventilation for bradycardia or ineffective respirations at birth

Intervention: Initiating positive pressure ventilation (PPV) with sustained inflation(s) >1 second (s) (SI)

Comparator: Initiating PPV with intermittent inflations, lasting ≤1 s per breath

Outcomes:

Primary Outcome: Death before hospital discharge (critical)

Secondary Outcomes:

• Death in the delivery room (critical); death within first 48 hours (critical); death at the latest follow-up (critical)
• Long term neurodevelopmental (ND) or behavioral or education outcomes at >18 months corrected age, using validated assessment tool(s) (critical)
• Use of mechanical ventilation during hospitalization (important)
• Air leaks (pneumothorax, pneumomediastinum, pneumopericardium, pulmonary interstitial emphysema) reported individually or as a composite outcome, at any time during initial hospitalization (important)
• Bronchopulmonary dysplasia, defined as use of supplemental oxygen at 28 days of age; need for supplemental oxygen at 36 weeks of gestational age for infants born at or before 32 weeks of gestation (latest reported outcome) (critical)
• Intraventricular hemorrhage, grade 3 or 4 (critical)
• Retinopathy of prematurity, stage 3 or above (critical)

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.

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 October 25, 2019.

PROSPERO Registration Submitted PROSPERO Registration, awaiting assignment of registration number

A priori subgroups to be examined:

• Preterm infants at ≤28+0 weeks, 28+1 to 31+6 weeks, 32+0 to 36+6 weeks, ≥37+0 weeks (term)
• Duration of 1st SI: 1-5 s, 6-15 s, >15 s
• Inflation pressure used during first SI: ≤20 cmH₂O, >20 cmH₂O
• Interface or device used to generate SI: Nasopharyngeal tube, endotracheal tube, face-mask or T-piece device vs. other device

A priori sensitivity analysis:

• Effects of whether studies allowed multiple sustained inflations
• Effects of the methodological quality of trials (to ascertain whether studies with high risk of bias overestimated treatment effects)

Consensus on Science

• For the critical outcome of death before discharge, evidence of low certainty (downgraded for risk of bias and inconsistency) from 10 RCTs {Linder 2005 303; Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; El-Chimi 2017 1273; El-Fattah 2017 409; Kirpalani 2019 1165; La Verde 2019 110} enrolling 1502 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV with sustained inflation(SI) >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 1.09; 95% CI 0.83-1.43; I² = 42%; 10 more patients/1000 died before discharge when SI was used [18 fewer to 47 more per 1000]).

• For the critical outcome of death in the delivery room, evidence of very low certainty (downgraded for risk of bias and very serious imprecision) from 9 RCTs {Linder 2005 303; Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; El-Chimi 2017 1273; El-Fattah 2017 409; La Verde 2019 110} enrolling 1076 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV with SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 2.82; 95% CI 0.45-17.66; I² = 0%; 4 more patients/1000 died in the delivery room with SI [95% CI, 1 fewer to 33 more per 1000]).

• For the critical outcome of death within 48 hours, low certainty evidence (downgraded for risk of bias and imprecision) from 10 RCTs {Linder 2005 303; Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; El-Chimi 2017 1273; El-Fattah 2017 409; Kirpalani 2019 1165; La Verde 2019 110} enrolling 1502 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed evidence of harm when initiating PPV with SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 2.42; 95% CI 1.15-5.09; I² = 10%; 18 more patients/1000 died within 48 hours with SI [95% CI, 2 more to 51 more per 1000]) The number needed to harm is 55 [95% CI, 20 - 500].

• For the critical outcome of long term neurodevelopmental or behavioural or educational outcomes, no studies were identified.

• For the critical outcome of death at latest follow up, no studies were identified.

• For the critical outcome of bronchopulmonary dysplasia, low certainty evidence (downgraded for risk of bias and imprecision) from 10 RCTs {Linder 2005 303; Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; El-Chimi 2017 1273; El-Fattah 2017 409; Kirpalani 2019 1165; La Verde 2019 110} enrolling 1502 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV with SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 0.93; 95% CI 0.79-1.10; I² = 8%; 19 fewer patients/1000 developed bronchopulmonary dysplasia with SI [95% CI, 58 fewer to 27 more per 1000]).

• For the critical outcome of intraventricular hemorrhage grade 3 or 4, low certainty evidence (downgraded for risk of bias and imprecision) from 9 RCTs {Linder 2005 303; Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; El-Fattah 2017 409; Kirpalani 2019 1165; La Verde 2019 110} enrolling 1390 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV with SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 0.88; 95% CI 0.63-1.23; I² = 0%; 11 fewer patients/1000 developed intraventricular haemorrhage grade 3 or 4 with SI[95% CI, 35 fewer to 22 more per 1000]).

• For the critical outcome of retinopathy of prematurity stage 3 or higher, low certainty evidence (downgraded for risk of bias and imprecision) from 9 RCTs {Linder 2005 303; Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; El-Fattah 2017 409; Kirpalani 2019 1165; La Verde 2019 110} reporting this outcome for 1342 of 1390 enrolled preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no benefit or harm when initiating PPV with SI >1 s when compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 0.83; 95% CI 0.62-1.11; I² =19% ; 22 fewer patients/1000 developed retinopathy of prematurity stage 3 or higher with SI [95% CI, 49 fewer to 14 more per 1000]). In one of the studies {Kirpalani 2019 1165}, this outcome was not available for 48 of the enrolled infants.

• For the important outcome of use of mechanical ventilation during hospitalization, low certainty evidence (downgraded for risk of bias and imprecision from 6 RCTs {Lista 2015 e457; Mercadante 2016 443; Jiravisitkul 2017 68; El-Chimi 2017 1273; El-Fattah 2017 409; La Verde 2019 110} enrolling 813 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no benefit or harm when initiating PPV with SI >1 s when compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 0.87; 95% CI 0.74-1.02; I² = 0%; 51 fewer patients/1000 used mechanical ventilation during the hospitalization with SI [95% CI, 103 fewer to 8 more per 1000]).

• For the important outcome of air leak during hospitalization, low certainty evidence (downgraded for risk of bias and imprecision) from 9 RCTs {Linder 2005 303; Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; El-Chimi 2017 1273; El-Fattah 2017 409; La Verde 2019 110} enrolling 1076 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV with SI >1 s when compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 1.26; 95% CI 0.72-2.21; I² = 17%; 9 more patients/1000 developed air leak during hospitalization with the SI [95% CI, 9 fewer to 41 more per 1000]).

Subgroup analysis for primary outcome:

1. Subgroup newborns <28+0 weeks

For the critical outcome of death before discharge, low certainty evidence (downgraded for risk of bias and imprecision) from 5 RCTs {Linder 2005 303; Lista 2015 e457; Jiravisitkul 2017 68; Ngan 2017 525; Kirpalani 2019 1165} enrolling 862 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed evidence of potential harm from initiating PPV with SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 1.38; 95% CI 1.00-1.91; I² = 0%; 46 more patients/1000 died before discharge with the SI [95% CI, 0 fewer to 110 more per 1000]) The number needed to harm is 22[95% CI, 9 - >1000].

1. Subgroup newborns 28+1 weeks to 31+6 weeks

For the critical outcome of death before discharge, very low certainty evidence (downgraded for risk of bias and very serious imprecision) from 4 RCTs {Linder 2005 303; Jiravisitkul 2017 68; Ngan 2017 525; La Verde 2019 110} enrolling 175 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV with SI >1 s when compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 1.33; 95% CI 0.22-8.20; I² = 5%; 4 more patients/1000 died before hospital discharge with SI [95% CI, 9 fewer to 86 more per 1000]).

1. Subgroup 1^st sustained inflation of 6-15 s duration

For the critical outcome of death before discharge, very low certainty evidence (downgraded for risk of bias, inconsistency and imprecision) from 9 RCTs {Linder 2005 303; Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; El-Chimi 2017 1273; El-Fattah 2017 409; Kirpalani 2019 1165; La Verde 2019 110} enrolling 1300 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV using SI >1 s when compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 1.10; 95% CI 0.83-1.46; I² = 45%; 12 more patients/1000 died before hospital discharge with SI [95% CI, 20 fewer to 53 more per 1000]).

1. Subgroup 1^st sustained inflation of >15 s duration

For the critical outcome of death before discharge, very low certainty evidence (downgraded for risk of bias and very serious imprecision) from 2 RCTs {Ngan 2017 525; El-Fattah 2017 409} enrolling 222 preterm newborns who received PPV for bradycardia for ineffective respirations at birth showed no significant benefit or harm from

initiating PPV using SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 0.70; 95% CI 0.31-1.60; I² = 31%; 28 fewer patients/1000 died before hospital discharge with SI [95% CI, 65 fewer to 57 more per 1000]).

1. Subgroup 1^st sustained inflation with inspiratory pressure >20 mmHg

For the critical outcome of death before discharge, low certainty evidence (downgraded for risk of bias and imprecision) from 6 RCTs {Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; La Verde 2019 110} enrolling 803 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV with SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 1.26; 95% CI 0.71-2.24; I² = 0%; 12 more patients/1000 died before hospital discharge with SI [95% CI, 14 fewer to 59 more per 1000]).

1. Subgroup 1^st sustained inflation with inspiratory pressure ≤20 mmHg

For the critical outcome of death before discharge, very low certainty evidence (downgraded for risk of bias, inconsistency and imprecision from 4 RCTs {Linder 2005 303; El-Chimi 2017 1273; El-Fattah 2017 409; Kirpalani 2019 1165} enrolling 699 preterm newborns who received PPV for bradycardia or ineffective respirations at birth could not exclude benefit or harm from initiating PPV with SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 1.04; 95% CI 0.77-1.42; I² = 69%; 7 more patients/1000 died before hospital discharge with SI [95% CI, 43 fewer to 73 more per 1000]).

Sensitivity analysis for primary outcome:

1. Excluding studies with very high risk of bias

For the critical outcome of death before discharge, low certainty evidence (downgraded for risk of bias and imprecision) from 9 RCTs {Linder 2005 303; Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; El-Fattah 2017 409; Kirpalani 2019 1165; La Verde 2019 110} enrolling 1390 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV with SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 1.24; 95% CI 0.92-1.68; I² = 24%; 21 more patients/1000 died before hospital discharge with SI [95% CI, 7 fewer to 61 more per 1000]).

1. Excluding studies that allowed only a single sustained inflation during resuscitation

For the critical outcome of death before discharge, low certainty evidence (downgraded for risk of bias and imprecision) from 9 RCTs {Linder 2005 303; Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; El-Chimi 2017 1273; Kirpalani 2019 1165; La Verde 2019 110} enrolling 1402 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV with SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 1.17; 95% CI 0.88-1.55; I² = 22%; 18 more patients/1000 died before hospital discharge with SI [95% CI, 13 fewer to 58 more per 1000]).

1. Sustained inflation with mask only

For the critical outcome of death before discharge, low certainty evidence (downgraded for risk of bias and imprecision from 9 RCTs {Lista 2015 e457; Schwaberger 2015 e0138964; Mercadante 2016 443; Jiravisitkul 2017 68; Ngan 2017 525; El-Chimi 2017 1273; El-Fattah 2017 409; Kirpalani 2019 1165; La Verde 2019 110} enrolling 1441 preterm newborns who received PPV for bradycardia or ineffective respirations at birth showed no significant benefit or harm from initiating PPV with SI >1 s compared to initiating PPV with intermittent inflations lasting ≤1 s per breath (RR = 1.06; 95% CI 0.61-1.39; I² = 42%; 7 more patients/1000 died before hospital discharge with SI [95% CI, 44 fewer to 44 more per 1000]).

Treatment Recommendations

For preterm newborn infants who receive positive pressure ventilation due to bradycardia or ineffective respirations at birth, we suggest against the routine use of initial sustained inflation(s) greater than 5 seconds (weak recommendation, low-certainty evidence). A sustained inflation may be considered in research settings.

For term or late preterm infants who receive positive pressure ventilation due to bradycardia or ineffective respirations at birth, it is not possible to recommend any specific duration for initial inflations due to the very low confidence in the estimates of effect.

Justification and Evidence to Decision Framework Highlights

• This topic was prioritized by the NLS Task Force following completion of a large RCT {Kirpalani 2019 1165} published after the previous CoSTR in 2015.{Perlman 2015 S204}
• In making these recommendations, the NLS Task Force considered the potential for increased death within 48 hours in preterm infants and increased death before discharge in preterm infants <28+0 weeks, a predefined subgroup of the systematic review. The Task Force recognizes that the outcome of death within 48 hours was mainly influenced by one study for which it was one of multiple secondary outcomes. {Kirpalani 2019 1165} The NLS Task Force also considered the absence of evidence for either benefit or harm following sustained inflation at birth for all other critical and important outcomes.
• The comparison of studies was compromised by methodological heterogeneity among studies, including indication, duration, and use of different inspiratory pressure during sustained inflation and the duration for which it was applied.
• No study was identified comparing short duration sustained inflation (< 5 seconds) with intermittent inflations with inspiratory time ≤ 1 second. There is no new evidence to support or refute the practice of initiating positive pressure ventilation with a series of inflations < 5 seconds immediately after birth.
• Hunt et al {Hunt 2019 17} was excluded from this systematic review because the control group received short duration sustained inflations (5 inflations of 2-3 s each) and the intervention group, sustained inflations of 15 s duration (ineligible as wrong comparator)
• A patent airway is necessary for effective lung inflation or ventilation. A recent study demonstrated that preterm rabbit pups are prone to closure of the larynx which opens only briefly during a spontaneous breath, thereby impeding noninvasive positive pressure ventilation after birth. {Crawshaw 2017 112}. Studies in preterm infants have shown that very little gas enters the lungs in the absence of spontaneous breathing suggesting that the same phenomenon occurs in preterm infants. {Van Vonderen 2014 903, Van Vonderen 2015 514} This PICOST (and most studies) focused on use of sustained inflation on newborns who are not breathing effectively, so inadequate patency of the larynx could explain the absence of benefit from sustained inflation immediately after birth in preterm infants. In addition, the NLS Task Force noted that mask leak or airway obstruction was not measured in the included studies and therefore, whether or not these factors influenced the effectiveness of sustained inflation as applied to the newborns in each study is unknown.
• How much of a role does glottis closure play in determining the effectiveness of sustained inflation in newborn infants of different gestations?
• What is the optimal duration, optimal inspiratory pressure and number of sustained inflation maneuvers that allow establishment of functional residual capacity without barotrauma?
• The NLS Task Force recognizes that the total number of infants studied thus far is insufficient to have confidence in the estimate of effect. Larger multi-centre trials are needed in both term and preterm newborns to determine whether there are benefits or harms from sustained inflations.
• Studies comparing short duration sustained inflation (< 5 seconds) with intermittent inflations with inspiratory time ≤ 1 seconds are needed. This is an important knowledge gap because the European Resuscitation Council currently recommends inflations of 2-3 seconds duration for the first five breaths in infants who are gasping or not breathing.
• Is there a role for sustained inflation for other situations in resuscitation such as cardiac compressions? (For more detail see evidence update for NLS 895 CPR Ratios)

Knowledge Gaps

Attachment: NLS-809-Sustained-Inflation-Et D-Table

References

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