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 member declared an intellectual conflict of interest and this was acknowledged and managed by the Task Force Chairs and Conflict of Interest committees: Daniele Trevisanuto authored two studies considered but excluded in the systematic review.
CoSTR Citation
de Almeida MF, Guinsburg R, Isayama T, Finan E, El-Naggar W, Fabres JG, Fawke J, Foglia EE, Kapadia VS, Kawakami MD, Kim HS, Lee HC, McKinlay CJD, Perlman JM, Rabi Y, Roehr CC, Schmölzer GM, Sugiura T, Trevisanuto D, Weiner GM, Wyllie JP, Liley HG,Wyckoff MH. Tactile stimulation for Resuscitation Immediately After Birth (NLS #1558) [Internet] Brussels, Belgium. International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force, Available from http://ilcor.org
Methodological Preamble (and Link to Published Systematic Review)
Tactile stimulation has been included in the initial steps of stabilization of the newborn infant in the treatment recommendations from ILCOR in 1999, 2006, 2010, 2015 and 2020 {Kattwinkel 1999 1927; ILCOR 2006 e-978; Perlman 2010 S516; Perlman 2015 S204; Wyckoff 2020 S185}, largely based on many years of experience and expert opinion. Because the effectiveness of tactile stimulation to facilitate breathing at birth has never been systematically evaluated by ILCOR, this PICOST was prioritized by the Neonatal Life Support Task Force.
The continuous evidence process for the creation of Consensus of Science and Treatment Recommendations (CoSTR) started with a systematic review of tactile stimulation for resuscitation immediately after birth (PROSPERO 2021 CRD 42021227768) conducted by Ruth Guinsburg, Maria Fernanda de Almeida, Emer Finan and Tetsuya Isayama. Evidence from neonatal literature was sought and considered by the Neonatal Life Support Task Force and clinical content experts. These data were taken into account when formulating the Treatment Recommendations.
Systematic Review
Guinsburg R, de Almeida MF, Finan E, Perlman JM, Wyllie JP, Liley HG, Wyckoff MH, Isayama T; for the International Liaison Committee On Resuscitation Neonatal Life Support Task Force. Tactile Stimulation in Newborns with Inadequate Respiration at Birth: A Systematic Review. Pediatrics 2022. In Press.
PICOST
The PICOST (Population, Intervention, Comparator, Outcome, Study Designs, and Time Frame)
• Population: Term or preterm newborn infants immediately after birth with absent, intermittent, or shallow respirations.
• Intervention: Any tactile stimulation performed within 60 seconds after birth and defined as one or more of the following: rubbing the chest/sternum; rubbing the back; rubbing the soles of the feet; flicking the soles of the feet; combination of these methods. This intervention should be done in addition to routine handling with measures to maintain temperature.
• Comparison: Routine handling with measures to maintain temperature, defined as care taken soon after birth, including positioning, drying and additional thermal care.
• Outcomes: The prespecified three primary outcomes were the establishment of spontaneous breathing without positive pressure ventilation (PPV; yes or no); time to the first spontaneous breath or crying from birth; and time to heart rate ≥100 bpm from birth. The following secondary outcomes were studied: survival as reported by authors; neurodevelopmental outcomes; intraventricular hemorrhage (only in preterm infants <34 weeks); oxygen and/or respiratory support at admission to a neonatal special or intensive care unit; and admission to a neonatal special or intensive care unit for those not admitted by protocol based on gestational age and/or birthweight.
Outcomes ratings using the GRADE classifications of critical or important (range 1-3 low importance for decision-making, 4-6 important but not critical for decision-making, 7-9 critical for decision-making) were decided according to a consensus for international neonatal resuscitation guidelines {Strand 2020 328}. Outcomes were converted into main outcomes and additional outcomes for submission to PROSPERO.
Potential subgroups were defined a priori: gestational age (<34 weeks, 34-36 6/7 weeks, and ≥37 weeks), cord management (early and delayed/cord milking), settings (high and low resource), and method of stimulation (type, number and/or duration of stimuli).
• Study Design: Randomized controlled trials (RCTs) and nonrandomized studies (non-RCTs, interrupted time series, controlled before-and-after studies, and cohort studies) were eligible for inclusion. Unpublished studies (conference abstracts, trial protocols) and animal studies were excluded.
• Timeframe: All years and all languages were included provided there was an English abstract. The literature search was first done on December 6, 2020 and updated on June 3, 2021 and September 17, 2021.
PROSPERO registration:
The review was registered with PROSPERO CRD 42021227768.
Risk of Bias
The risk of bias of each included study was assessed by ROBINS-I tool {Sterne 2016 i4919} as low, moderate, serious, or critical according to the following domains: confounding, selection of participants into the study, classification of interventions, deviations from intended interventions, missing data, and selection of the reported result.
For studies without critical risk of bias in which authors compared either primary or secondary outcomes between infants receiving tactile stimulation and those not, a meta-analysis with random-effect Mantel-Haenszel methods was planned. If only a single study provided outcome data, the risk ratio (RR) and the 95% confidence intervals (CIs) were calculated with unconditional maximum likelihood estimation using R version 3.6.1 (R Foundation for Statistical Computing: Vienna, Austria).
The certainty of evidence was judged as high, moderate, low, or very low for each outcome based on the GRADE approach by judging the risk of bias, indirectness, imprecision, inconsistency, and other consideration (e.g. publication bias) {Guyatt 2008 924}. Because we used ROBINS-I, an initial assumption of high certainty of evidence was applied for observational studies as well as for RCTs according to the recommendation from the GRADE group {Schünemann 2019 105}.
Consensus on Science
COMPARISON: Any tactile stimulation performed within 60 seconds after birth in addition to routine handling with measures to maintain temperature vs. routine handling with measures to maintain temperature
The systematic review identified two observational studies {Baik-Schneditz 2018 952; Dekker 2017 61}. The study by Baik-Schneditz was not eligible for data analysis due to its critical risk of bias (mainly by confounding by indication). Therefore, only the study by Dekker et al with 245 preterm newborn infants was analyzed.
For the important outcome of tracheal intubation in delivery room, evidence of very low certainty (downgraded for risk of bias, indirectness, and imprecision, and upgraded by the strong association) from 1 observational trial {Dekker 2017 61} involving 245 preterm newborns showed possible benefit from receiving tactile stimulation in addition to routine handling compared to routine handling only (including measures to maintain temperature) (RR 0.41, 95%CI 0.20-0.85; ARD 105/1000 fewer newborns with tracheal intubation when receiving tactile stimulation, 95%CI 142/1000 fewer to 27/1000 fewer).
For the important primary outcomes of establishment of spontaneous breathing without PPV, time to the first spontaneous breath or crying, and time to heart rate ≥100 bpm, no data were reported in the included study.
For the critical secondary outcomes of survival, neurodevelopmental outcomes, and intraventricular hemorrhage in preterm infants <34 weeks, no data were reported in the included study.
For the important secondary outcomes of admission to a neonatal special unit or intensive care unit and oxygen and/or respiratory support at admission, no data were reported in the included study.
Subgroup Analyses:
No data were reported to perform subgroup analyses by gestational age (<34 weeks, 34-36 6/7 weeks, and ≥37 weeks), cord management (early and delayed/cord milking), settings (high and low resourced), and method of stimulation (type, number and/or duration of stimuli)
Treatment Recommendations
We suggest it is reasonable to apply tactile stimulation in addition to routine handling with measures to maintain temperature in newborn infants with absent, intermittent, or shallow respirations during resuscitation immediately after birth (weak recommendation, with very low certainty due to risk of bias, indirectness, and imprecision). Tactile stimulation should not delay the initiation of positive pressure ventilation for newborns who continue to have absent, intermittent, or shallow respirations after birth.
Justification and Evidence to Decision Framework Highlights
In making these recommendations, the Neonatal Life Support Task Force acknowledges the following:
- The very limited available data suggest a possible benefit to tactile stimulation in decreasing the need for tracheal intubation in preterm infants, but the certainty of evidence is very low. This benefit was found in a single retrospective cohort study {Dekker 2017 61} involving 245 preterm newborns <32 weeks of gestational age. The results of this study should be analyzed with caution due to indirectness (all 245 infants were put on CPAP before tactile stimulation in contrast to the common practice of tactile stimulation before CPAP or positive pressure ventilation), possible selection bias (among 673 infants who were video recorded immediately after birth, 245 (36%) were included in the study), and confounding (the clinical indication of tactile stimulation was retrospectively assessed and it could not be determined in 34% of the 585 tactile stimulation episodes).
- Observational studies showed that, in general, infants who received tactile stimulation responded with crying, grimacing and body movements, although the methods of stimulation were variable and the outcomes analyzed were not exactly the same among the studies {Gaertner 2018 F132; Katheria 2016 75; Pietravalle 2018 306; Van Henten 2019 F661}. These studies could not be included in the systematic review due the lack of control groups who did not receive tactile stimulation.
- A single center RCT compared single vs. repetitive tactile stimulation in preterm infants immediately after birth. Patients in the repetitive stimulation group had higher oxygen saturation levels and lower oxygen requirements at the start of transport to the NICU {Dekker 2018 37}. This study could not be included in the systematic review due to the lack of control group who did not receive tactile stimulation.
- A single center RCT compared back rubbing vs. foot flicking to provide tactile stimulation in preterm and term infants with birthweight >1500g who did not cry at birth. There was no difference between both techniques in achieving effective crying to prevent the need of PPV {Cavallin 2021 137}. This study could not be included in the systematic review due to the lack of a control group who did not receive tactile stimulation.
- In studies that analyze a bundle of procedures to stimulate respiratory transition at birth in low resource settings, tactile stimulation together with upper airway suction triggered the initiation of spontaneous respirations {Ersdal 2012 869; Msemo 2013 e353}. These studies could not be included in the systematic review due to the inability to isolate the effects of tactile stimulation as well as the lack of a control group.
Despite the possible benefits outlined above, there are some concerns related to possible adverse effects of tactile stimulation in delaying the initiation of ventilation beyond 60 seconds after birth, which may then compromise the efficacy of the overall resuscitation {Cavallin 2021 137; KC 2021 235; Pietravalle 2018 306}. Also, there is a report of soft tissue trauma after tactile stimulation {Kalaniti 2017 84].
Knowledge Gaps
- Effect of tactile stimulation on the main outcomes: breathing without PPV; time to the first spontaneous breath or crying from birth; and time to heart rate ≥100 bpm from birth
- Effect of tactile stimulation on secondary outcomes: death in the delivery room, hospital death; neurodevelopmental outcomes; intraventricular hemorrhage only in preterm infants; oxygen and/or respiratory support at admission to a neonatal special unit or intensive care unit; and admission to a neonatal special or intensive care unit for those not admitted by protocol.
- Effects of tactile stimulation in different gestational ages.
- Effects of tactile stimulation with different cord management strategies.
- Which patients benefit from tactile stimulation (all, patients with apnea, irregular breathing or other): what is the indication of tactile stimulation
- Efficacy of different methods of tactile stimulation (rubbing, flicking or other)
- Efficacy of stimulation in different parts of the body (soles of the feet, back, chest or other)
- When to start tactile stimulation after birth and when to stop
- Duration of each stimulus (seconds)
- Optimal number of stimuli
- Optimal duration of stimulation before providing respiratory support (seconds)
- Adverse effects of tactile stimulation
Attachments
NLS 5140 Tactile Stimulation Et D FINAL 12 21 21
References
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