Tracheal suctioning of meconium at birth for non-vigorous infants: a systematic review and meta-analysis (NLS#865)

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Final draft

This CoSTR is a draft version prepared by ILCOR and is labelled “draft” to comply with copyright rules of journals. The final COSTR will be published on this website once a summary article has been published in a scientific journal and labeled as “final”.

Tracheal suctioning of meconium at birth for non-vigorous infants: a systematic review and meta-analysis (NLS#865)

Comments received on the Draft for Public Comment

There were 8000 hits and the majority of feedback for the CoSTR was positive (60%). However, there were concerns about clarity which we have tried to address and a few commentators were against the treatment recommendations but unfortunately did not offer any evidence for their assertions.

The ILCOR Neonatal Task Force is not able to make changes based on anecdote, although treatment recommendations and suggestions do not preclude clinicians making treatment decisions appropriate to individual cases as long as they can be justified.

The task force has taken on board the constructive feedback and adjusted the wording of the treatment recommendation and justification and evidence to decision tale as well as the Gaps in knowledge. You can read the adjusted version below.

CoSTR Citation

Strand ML, Lee HC, Kawakami M, Fabres J, Nation K, Rabi Y, Szyld E, Wyckoff MH, Wyllie J, Trevisanuto D. Tracheal suctioning of meconium at birth for non-vigorous infants: a systematic review and meta-analysis . [Internet] Brussels, Belgium: International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force, 2019 July 26. Available from: http://ilcor.org

Collaborators

Jeffrey M. Perlman, Khalid Aziz, Ruth Guinsburg, Maria Fernanda de Almeida, Vishal Kapadia, Sithembiso Velaphi, Lindsay Mildenhall, Helen Liley, Shigeharu Hosono, Han-Suk Kim, Tetsuya Isayama and Charles Christoph Roehr.

Methodological Preamble and Link to Published Systematic Review

The continuous evidence process for the production of Consensus on Science with Treatment Recommendations (CoSTR) started with a systematic review of available literature regarding the treatment of newborns born through meconium-stained amniotic fluid and non-vigorous at the time of delivery (http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42019122778) conducted by Ms. Carolyn Ziegler, Toronto, Canada with involvement of clinical content experts. Evidence for neonatal literature was sought and considered by the Neonatal Life Support Task Force. These data were taken into account when formulating the Treatment Recommendations.

Systematic Review: Reference not yet available

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

Population: Non-vigorous infants born at ≥ 34 weeks’ gestation delivered through meconium-stained amniotic fluid of any consistency (non-vigorous defined as heart rate <100 bpm, decreased muscle tone and/or depressed breathing at delivery).

Intervention: Performing immediate laryngoscopy with or without intubation and suctioning at the start of resuscitation.

Comparison: Performing immediate resuscitation without direct laryngoscopy at the start of resuscitation.

Survival to hospital discharge (Primary)

Neurodevelopmental impairment (Secondary)

Meconium aspiration syndrome (Secondary)

Other respiratory outcomes - continuous positive airway pressure or mechanical ventilation, treatment of pulmonary hypertension with inhaled nitric oxide, oral medications or extracorporeal membrane oxygenation (Secondary)

Delivery room interventions - cardiopulmonary resuscitation/medications, intubation for positive pressure ventilation (Secondary)

Length of hospitalization (Secondary)

Study Designs: Randomized controlled trials (RCT) and non-randomized studies (non-randomized controlled trials, interrupted time series, controlled before-and-after studies, and cohort studies) were included in the review.

Timeframe: All years and all languages were included as long as there was an English abstract; unpublished studies (e.g., conference abstracts, trial protocols) and animal studies were excluded. Literature search updated to May 2019.

A priori subgroups to be examined: Consistency of meconium (thin vs thick), gestational age categories (late preterm (34-36+6/7 weeks), term (37-40+6/7 weeks), post-term (≥42 weeks)), presence or absence of fetal bradycardia, route of delivery (spontaneous vaginal, instrumented vaginal, caesarean section), direct laryngoscopy with vs without suctioning.

PROSPERO Registration: CRD42019122778

Consensus on Science

For the critical outcome of survival to discharge, we have identified low certainty evidence (downgraded for inconsistency and imprecision) from 3 RCTs (Chettri 2015 1208, Nangia 2016 79, Singh 2018 ) enrolling 449 non-vigorous newborns delivered through meconium-stained amniotic fluid (MSAF) which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR, 0.99; 95% CI, 0.93-1.06; p=0.87; absolute risk reduction [ARR], -0.9%; 95% CI -6.4% to 5.5%, or 9 fewer patients/1000 survived to discharge with the intervention [95% CI, 64 fewer patients/1000 to 55 more patients/1000 survived to discharge with the intervention]).

For the critical outcome of cognitive neurodevelopmental impairment, we have identified very low certainty evidence (downgraded for risk of bias, indirectness and imprecision) from 1 RCT (Chettri 2015 1208) enrolling 86 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR, 0.75; 95% CI, 0.37-1.50; p=0.41; absolute risk reduction [ARR], -8%; 95% CI -20% to 15.9%, or 80 fewer patients/1000 with mental neurodevelopmental impairment with the intervention [95% CI, 200 fewer patients/1000 to 159 more patients/1000 with mental neurodevelopmental impairment with the intervention]). The neurodevelopmental assessment from this one study was done at an early and non-standard time, hence the results are poorly predictive of longer-term outcomes. The effect of the intervention on neurodevelopmental impairment remains uncertain.

For the critical outcome of motor neurodevelopmental impairment, we have identified very low certainty evidence (downgraded for risk of bias, indirectness and imprecision) from 1 RCT (Chettri 2015 1208) enrolling 86 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR, 0.91; 95% CI, 0.49-1.67; p=0.76; absolute risk reduction [ARR], -3.1%; 95% CI -17.4% to 22.8%, or 31 fewer patients/1000 with motor neurodevelopmental impairment with the intervention [95% CI, 174 fewer patients/1000 to 228 more patients/1000 with motor neurodevelopmental impairment with the intervention]). The neurodevelopmental assessment from this one study was done at an early and non-standard time, hence the results are poorly predictive of longer-term outcomes. The effect of the intervention on neurodevelopmental impairment remains uncertain.

For the critical outcome of hypoxic ischemic encephalopathy, we have identified very low certainty evidence (downgraded for risk of bias, inconsistency and imprecision) from 2 RCTs (Nangia 2016 79, Singh 2018) enrolling 327 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR, 0.86; 95% CI, 0.62-1.18; p=0.34; absolute risk reduction [ARR], -4.8%; 95% CI -13.1% to 6.2%, or 48 fewer patients/1000 with hypoxic ischemic encephalopathy with the intervention [95% CI, 131 fewer patients/1000 to 62 more patients/1000 with hypoxic ischemic encephalopathy with the intervention]).

For the critical outcome of meconium aspiration syndrome (MAS), we have identified very low certainty evidence (downgraded for risk of bias, inconsistency and imprecision) from 3 RCTs (Chettri 2015 1208, Nangia 2016 79, Singh 2018) enrolling 449 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR, 0.93; 95% CI, 0.73-1.19; p=0.57; absolute risk reduction [ARR], -2.7%; 95% CI -10.3% to 4.5%, or 27 fewer patients/1000 with MAS with the intervention [95% CI, 103 fewer patients/1000 to 45 more patients/1000 with MAS with the intervention]).

For the important outcome of use of mechanical ventilation, we have identified low certainty evidence (downgraded for risk of bias and imprecision) from 3 RCTs (Chettri 2015 1208, Nangia 2016 79, Singh 2018) enrolling 449 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR, 1.00; 95% CI, 0.66-1.53; p=0.99; absolute risk reduction [ARR], 0%; 95% CI -5.4% to 8.4%, or 0 fewer patients/1000 received mechanical ventilation with the intervention [95% CI, 54 fewer patients/1000 to 84 more patients/1000 received mechanical ventilation with the intervention]).

For the important outcome of use of respiratory support excluding mechanical ventilation, we have identified low certainty evidence (downgraded for risk of bias and imprecision) from 2 RCTs (Nangia 2016 79, Singh 2018) enrolling 327 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR, 0.99; 95% CI, 0.81-1.20; p=0.88); absolute risk reduction [ARR], -0.4%; 95% CI -7.3% to 7.6%, or 4 fewer patients/1000 received respiratory support excluding mechanical ventilation with the intervention [95% CI, 73 fewer patients/1000 to 76 more patients/1000 received respiratory support excluding mechanical ventilation with the intervention]).

For the important outcome of endotracheal intubation for PPV in the delivery room, we have identified low certainty evidence (downgraded for risk of bias and imprecision) from 2 RCTs (Chettri 2015 1208, Nangia 2016 79) enrolling 297 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR, 1.15; 95% CI, 0.83-1.59; p=0.40; absolute risk reduction [ARR], 4.1%; 95% CI -4.7% to 16.2%, or 41 more patients/1000 received endotracheal intubation in the delivery room with the intervention [95% CI, 47 fewer patients/1000 to 162 more patients/1000 received endotracheal intubation in the delivery room with the intervention]).

For the important outcome of chest compressions in the delivery room, we have identified very low certainty evidence (downgraded for risk of bias and imprecision) from 3 RCTs (Chettri 2015 1208, Nangia 2016 79, Singh 2018) enrolling 449 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR, 1.13; 95% CI, 0.40-3.20; p=0.82; absolute risk reduction [ARR], 0.4%; 95% CI -1.9% to 6.8%, or 4 more patients/1000 received chest compressions in delivery room with the intervention [95% CI, 19 fewer patients/1000 to 68 more patients/1000 received chest compressions in the delivery room with the intervention]).

For the important outcome of use of epinephrine in the delivery room, we have identified very low certainty evidence (downgraded for risk of bias and imprecision) from 3 RCTs (Chettri 2015 1208, Nangia 2016 79, Singh 2018) enrolling 449 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR,1.62; 95% CI, 0.37-7.05; p=0.52; absolute risk reduction [ARR], 0.8%; 95% CI -0.8% to 8%, or 8 more patients/1000 received epinephrine in delivery room with the intervention [95% CI, 8 fewer patients/1000 to 80 more patients/1000 received epinephrine in the delivery room with the intervention]).

For the important outcome of treatment of pulmonary hypertension (iNO, medications, ECMO), we have identified very low certainty evidence (downgraded for risk of bias, indirectness and imprecision) from 1 observational study (Chiruvolu 2018 e20181485) enrolling 231 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (RR, 0.52; 95% CI 0.15-1.79; p=0.30; absolute risk reduction [ARR], -2.9%; 95% CI -5% to 4.7%, or 29 fewer patients/1000 received treatment of pulmonary hypertension (iNO, medications, ECMO) with the intervention [95% CI, 50 fewer patients/1000 to 47 more patients/1000 received treatment of pulmonary hypertension (iNO, medications, ECMO) with the intervention]).

For the important outcome of length of hospitalization, we have identified very low certainty evidence (downgraded for risk of bias, inconsistency and imprecision) from 2 RCTs (Nangia 2016 79, Singh 2018) enrolling 327 non-vigorous newborns delivered through MSAF which showed no benefit for the use of immediate laryngoscopy with or without tracheal suctioning when compared to immediate resuscitation without laryngoscopy (mean difference, 0.5 days lower; 95% CI, 1.76 days lower to 0.75 days higher; p=0.43).

Treatment Recommendations

For non-vigorous newborns delivered through meconium-stained amniotic fluid, we suggest against routine immediate direct laryngoscopy after delivery with or without tracheal suctioning when compared to immediate resuscitation without direct laryngoscopy. Meconium-stained amniotic fluid remains a significant risk factor for receiving advanced resuscitation in the delivery room. Rarely, an infant may require intubation and tracheal suctioning to relieve airway obstruction.

Justification and Evidence to Decision Highlights

The Task Force recognizes that, while the Treatment Recommendation has not changed, several studies have been added to the literature since the last recommendation was made. While these studies contribute new evidence regarding this topic, the certainty of the findings remains low or very low due to the difficulty of performing unbiased studies of this clinical question as well as failure of the data to reach optimal information size.

In making this suggestion, we place value on both harm avoidance (delays in providing bag-mask ventilation, potential harm of the procedure) and the unknown benefit of routine tracheal intubation and suctioning.

Routine suctioning of non-vigorous infants is more likely to result in delays in initiating ventilation, especially where the provider is unable to promptly intubate the infant or suction attempts are repeated. In the absence of evidence of benefit for routine suctioning, the emphasis should be on initiating ventilation within the first minute of life in non-breathing or ineffectively breathing infants born through meconium-stained amniotic fluid. Some newly born infants may receive tracheal intubation in order to clear a blocked airway or for subsequent ventilation (Edwards 2019 E68, Kalra 2019).

Knowledge Gaps

Despite the addition of several randomized trials focused on this clinical question, the optimal information size is not achieved even with all of the studies taken together. The difficulties of performing a study while minimizing the risks of bias due to difficulty with blinding and assessment of outcome make accrual of evidence a significant challenge. The priorities for study remain similar to previous versions of the CoSTR:

  • Does the potential for harm (i.e. delay in starting positive pressure ventilation or transient bradycardia/hypoxia, mortality, NDI) outweigh the potential for benefit (i.e. reduction of MAS, need for mechanical ventilation or treatment of pulmonary hypertension)?
  • Do risks or benefits of intubation with tracheal suctioning vary with any subgroup (gestational age, thickness of meconium, operator experience)?
  • Long-term outcomes should be included in future studies.
  • The neurodevelopmental, behavioural, or educational assessment for future studies should be at or after 18 months of age and completed with a validated tool.

Attachments

Evidence-to-Decision Table: Should ETT suction vs. No ETT suction be used for non-vigorous infants: a systematic review and meta- analysis?

References

Chettri S, Adhisivam B, Bhat BV. Endotracheal suction for nonvigorous neonates born through meconium stained amniotic fluid: a randomized controlled trial. J Pediatr 2015;166:1208-13.

Chiruvolu A, Miklis KK, Chen E, Petrey B, Desai S. Delivery room management of meconium-stained newborns and respiratory support. Pediatrics 2018;142(6):e20181485.

Nangia S, Sunder S, Biswas R, Saili A. Endotracheal suction in term non vigorous meconium stained neonates—a pilot study. Resusitation 2016;105:79-84.

Singh SN, Saxena S, Bhriguvanshi A, Kumar M, Chandrakanta, Sujata. Effect of endotracheal suctiooing just after birth in non-vigorous infants born through meconium stained amniotic fluid: A randomized controlled trial. Clin Epid and Global Health 2018. https://doi.org/10.1016/j.cegh.2018.03.006

Edwards EM, Lakshminrusimha S, Ehret DEY, Horbar JD. NICU Admissions for Meconium Aspiration Syndrome before and after a National Resuscitation Program Suctioning Guideline Change. Children (Basel). 2019;6(5). pii: E68.

Kalra VK, Lee HC, Sie L, Ratnasiri AW, Underwood MA, Lakshminrusimha S. Change in neonatal resuscitation guidelines and trends in incidence of meconium aspiration syndrome in California. J Perinatol. 2019. doi: 10.1038/s41372-019-0529-0. [Epub ahead of print]



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