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Continuous Positive Airway Pressure (CPAP) versus no CPAP For Term Respiratory Distress in Delivery Room (NLS #5312)

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This CoSTR is a draft version prepared by ILCOR, with the purpose to allow the public to comment and is labeled “Draft for Public Comment". The comments will be considered by ILCOR. The next version will be 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”.

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:

One author (GMS) was a co-author of one of the screened studies. He was excluded from screening of this study.

CoSTR Citation

Shah BA, Fabres JG, Szyld EG, Leone TA, Schmölzer GM, de Almeida MF, Costa-Nobre DT, Davis PG, El-Naggar W, Fawke J, Foglia EE, Guinsburg R, Isayama T, Kapadia VS, Kawakami MD, Kim HS, Lee HC, Madar RJ, McKinlay CJD, Nakwa FL, Perlman JM, Rabi Y, Roehr CC, Rüdiger M, Sugiura T, Trevisanuto D, Weiner GM, Wyllie JP, Liley HG, Wyckoff MH. Continuous positive airway pressure versus no continuous positive airway pressure for term and late preterm respiratory distress in the delivery room (NLS#5312 [Internet] Brussels, Belgium. International Liaison Commiittee on Resuscitation (ILCOR) Neonatal Life Support Task Force, Available from http://ilcor.org

Methodological Preamble (and Link to Published Systematic Review)

Continuous Positive Airway Pressure (CPAP) has been included in the neonatal resuscitation algorithm to help infants with persistent labored breathing or cyanosis after the initial steps of resuscitation. For spontaneously breathing preterm newborn infants with respiratory distress requiring respiratory support in the delivery room, ILCOR has suggested initial use of CPAP rather than intubation and intermittent positive pressure ventilation (PPV). {Wyckoff 2020 S185}. Although it has become increasenly frequent to provide CPAP in the delivery room for late preterm and term infants, this practice has not been systematically evaluated by ILCOR and therefore this PICOST has been prioritized by the Neonatal Life Support Task Force.

The continuous evidence evaluation process for the creation of Consensus of Science and Treatment Recommendations (CoSTR) started with a systematic review of Continuous Positive Airway Pressure (CPAP) versus no CPAP For Term Respiratory Distress in Delivery Room (PROSPERO 2021 CRD42021225812) conducted by Birju Shah, Edgardo Szyld, Jorge Fabres, Tina Leone and Georg Schmölzer. 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

Reference not yet available

PICOST

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

Population: In spontaneously breathing newly born ≥34+0 weeks’ gestation infants with respiratory distress and/or low oxygen saturations during transition after birth.

Intervention: Continuous positive airway pressure (CPAP) at different levels with or without supplemental oxygen.

Comparison: No CPAP with or without supplemental oxygen.

  • · Outcomes: The prespecified primary outcome was admissions to neonatal intensive care unit (NICU) or higher level of care receiving any positive pressure support. The following secondary outcomes were studied: Receiving tracheal intubation or chest compressions in the delivery room, use and duration of respiratory support in NICU, air-leak syndromes including pneumothorax and pneumomediastinum, death at hospital discharge, length of hospital stay, and moderate-severe neurodevelopmental impairment (>18 months).

Study Design: Randomized controlled trials (RCTs) and nonrandomized studies (non-RCTs, interrupted time series, controlled before-and-after studies, cohort studies, and simulation studies) were eligible for inclusion. Unpublished studies (e.g., conference abstracts, trial protocols) and animal studies were excluded.

Timeframe: All years and all languages were included if an English abstract was available. The literature search was first performed on November 30, 2020 and updated on October 11, 2021.

PROSPERO registration:

The review was registered with PROSPERO CRD42021225812 on January 18, 2021.

Bias and certainty assesment:

For each study, pairs of authors independently extracted pre-determined study characteristics and study outcomes and then achieved consensus. Pairs of independent authors evaluated risk of bias (RoB) in individual studies using the Cochrane Risk of Bias Tool for RCTs and the Risk of Bias in Non-Randomized Studies of Interventions Tool (ROBINS-I) for observational studies. {Sterne 2016 i4919; Higgins 2011 d5928}. Similarly, two authors assessed the certainty of evidence (confidence in the estimate of effect) for each outcome based upon the GRADE framework including calculating the optimal information size in order to assess imprecision (GRADEproGuideline Development Tool, McMaster University, 2015, available from gradepro.org) {Higgins 2011 d5928; Schunemann 2013 49} The RoB and GRADE assessments were then reviewed by ILCOR content experts to achieve consistency and consensus.

Consensus on Science

COMPARISON: Continuous positive airway pressure (CPAP) at different levels with or without supplemental oxygen vs. no CPAP with or without supplemental oxygen.

The systematic review identified two RCTs {Celebi 2016 99; Osman 2019 597} and two observational studies, one of which was divided in two publications {Hishikawa 2015 F382; Hishikawa 2016 1; Smithhart 2019 e20190756}. Relevant data from the author via electronic communications have been collated into one study for purpose of this meta-analysis {Hishikawa 2015 F382; Hishikawa 2016 1}.

For the important outcome of NICU admissions we have identified very low-certainty evidence (downgraded for imprecision and risk of bias) from two RCTs {Celebi 2016 99; Osman 2019 597} enrolling 323 infants born by caesarean section with or without respiratory distress showing benefit with the use of early CPAP (absolute effect 94 fewer per 1,000; 95% CI 115 fewer to 44 fewer per 1,000, number needed to treat 11; 95% CI 9 to 23).

For the important outcome of air leak syndromes we have identified very low-certainty evidence (downgraded for risk of bias) from two observational studies {Hishikawa 2015 F382; Hishikawa 2016 1; Smithhart 2019 e20190756} enrolling 8476 infants showing positive association with CPAP use and air leak syndromes (absolute effect 133 more per 1,000; 95% CI 106 more to 166 more per 1,000). The two RCTs available for this review comparing 168 subjects with CPAP of 5 cm H2O versus 155 subjects with no CPAP reported no cases of pulmonary air leak.

For the important outcome of NICU respiratory support we identified very low-certainty evidence (downgraded for risk of bias and imprecision) from two RCTs {Celebi 2016 99; Osman 2019 597} enrolling 323 infants showing benefit with the use of early CPAP (absolute effect 79 fewer per 1,000; 95% CI 91 fewer to 39 fewer per 1,000, number needed to treat 13; 95% CI 11 to 26).

For the critical outcome of death at discharge we identified very low-certainty evidence (downgraded for risk of bias and imprecision) from two RCTs {Celebi 2016 99; Osman 2019 597} enrolling 323 infants showing we could not exclude benefit or harm (absolute effect 5 fewer per 1,000; 95% CI 6 fewer to 39 more per 1,000).

For the important outcome of tracheal intubation or chest compressions in the delivery room we did not identify any evidence in the included studies.

For the critical outcome of neurodevelopmental impairment we did not identify any evidence in the included studies.

Subgroup Analyses:

Not enough data were reported to perform prespecified subgroup analyses on late preterm (34+0-36+6 weeks), term (37+0-41+6 weeks), post term (greater than or equal to 42 weeks); mode of delivery: caesarean section versus vaginal delivery; any previous positive pressure support (positive pressure ventilation or sustained inflation); supplemental oxygen for targeting oxygen saturation goals; mode of support: interface (facemask vs. nasal prongs/cannula); device (T-piece vs. flow-Inflating bag) and level of continuous positive airway pressure support: high continuous positive airway pressure (>6 cm H2O) versus low continuous positive airway pressure (4-6 cm H2O).

Treatment Recommendations

For spontaneously breathing late preterm and term newborn infants in the delivery room with respiratory distress, there is insufficient evidence to suggest for or against routine use of CPAP compared with no CPAP.

Justification and Evidence to Decision Framework Highlights

In making this recommendation, the Neonatal Life Support Task Force acknowledges the following:

  • The use of CPAP in the delivery room has been recommended for infants with persistent signs of respiratory distress, labored breathing or cyanosis after the initial steps of resuscitation. This has been mainly extrapolated from evidence in preterm patients. The benefits and risks in late preterm and term infants had not previously been systematically reviewed.
  • The two RCTs included only 323 subjects, who were all delivered by cesarean section (one RCT enrolled 259 newborns used prophylactic CPAP).
  • Within the observational studies we identified a positive association between the use of CPAP and the presence of air leak syndromes (one nested cohort study included only infants admitted to the NICU).
  • Therefore, in making this recommendation, we integrate the values placed on avoidance of potential harm as noted by the positive association between CPAP use and air leak syndromes and potential benefit as noted by the reduction in NICU admission among infants born by cesarean section.

Knowledge Gaps

Several knowledge gaps are identified after this review:

  • Large multicenter RCTs evaluating the effect of delivery room CPAP for late preterm and term newborns with respiratory distress are needed.
  • The two RCTs identified included infants delivered by cesarean section only. Hence, the effect of CPAP in the delivery room for late preterm and term infants delivered vaginally needs to be studied. Additionally, future studies should evaluate the impact of labor on outcomes when CPAP is used for respiratory distress in the delivery room.
  • Other comparisons that need evaluation: the effect of CPAP among different populations: late preterm vs term and post term patients; the effect of CPAP after any previous positive pressure support (positive pressure ventilation or sustained inflation); the potential different effects of CPAP with or without the use supplemental oxygen; the effect of the modes of support: interfaces (facemask vs. nasal prongs/cannula vs. alternative airway), devices (T-piece vs. flow-Inflating bag); and level of continuous positive airway pressure support: high continuous positive airway pressure (>6 cm H2O) versus low continuous positive airway pressure (4-6 cm H2O).

Attachments

NLS5312 CPAP vs No CPAP Et D

References

Celebi MY, Alan S, Kahvecioglu D, Cakir U, Yildiz D, Erdeve O, et al. Impact of Prophylactic Continuous Positive Airway Pressure on Transient Tachypnea of the Newborn and Neonatal Intensive Care Admission in Newborns Delivered by Elective Cesarean Section. Am J Perinatol. 2016 Jan;33(1):99-106.

Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011 Oct 18;343:d5928.

Hishikawa K, Goishi K, Fujiwara T, Kaneshige M, Ito Y, Sago H. Pulmonary air leak associated with CPAP at term birth resuscitation. Arch Dis Child Fetal Neonatal Ed. 2015 Sep;100(5): F382-7.

Hishikawa K, Fujinaga H, Fujiwara T, Goishi K, Kaneshige M, Sago H, et al. Respiratory Stabilization after Delivery in Term Infants after the Update of the Japan Resuscitation Council Guidelines in 2010. Neonatology. 2016;110(1):1-7.

Osman AM, El-Farrash RA, Mohammed EH. Early rescue Neopuff for infants with transient tachypnea of newborn: a randomized controlled trial. J Matern Fetal Neonatal Med. 2019 Feb;32(4):597-603.

Smithhart W, Wyckoff MH, Kapadia V, Jaleel M, Kakkilaya V, Brown LS, et al. Delivery Room Continuous Positive Airway Pressure and Pneumothorax. Pediatrics. 2019 Sep;144(3):e20190756.

Sterne JA, Hernán MA, Reeves BC, Savović J, Berkman Nancy D, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016 Oct;355:i4919.

Schünemann H, Brożek J, Guyatt G, Oxman A. GRADE Handbook. https://gdt.gradepro.org/app/handbook/handbook.html

Wyckoff MH, Wyllie J, Aziz K, De Almeida MF, Fabres J, Fawke J, et al. Neonatal Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct;142(16_suppl_1):S185-S221.

Neonatal life support
Airway and ventilation
CPAP, respiratory distress,, delivery room

Discussion

GUEST
Srabani Samanta

(modified: )

Effect of CPAP vs No CPAP in DR for late preterm and term infants with respiratory distress undergoing physiological umbilical cord clamping
Reply
GUEST
Gislayne Nieto

(modified: )

In our service we use CPAP in the delivery room in newborns > 34 weeks with mild to moderate distress for up to 1 hour. If they do not improve, they are admitted to the ICU .We are trying to analyze our data regarding the success and failure of this technique in our service
GUEST
Giselda Silva

(modified: )

we do cpap in preterm infants with mild respiratory distress after physiological cord clamping in 30 seconds
Reply
GUEST
Marinice Ponte

(modified: )

In the past, for each late preterm or term neonate who developed respiratory distress after delivery, were submitted to hood for 3, 4, 6 hours of life before admission in NCIU. During this period, many of them became better, but about 25% sustained distress and your complications (pneumothorax or pulmonary hypertension, for instance). Since 2020 we have used CPAP instead hood, in according to the manual of care post reanimation. We have followed the Downes Index recommendations, and offer oxigen, CPAP or only observation in delivery room around one hour, if they are stable. If they become better, stay with their mothers. If they don’t normalize their status or became worse , they are admitted in NCIU. Changing our procedures have showed us this babys (around 40 neonates/month) have better disclosure. We have 800 -1000 deliveries per month, most of them by cesarean before the beginning of labour, as in most of private hospitals here in Brasil. So, I think our not controlled experience (we don’t have any indicators) justify for us at least, we need mantain this approach. If ILCOR could help and teach us to develop studies in this field, perhaps we could contribute to this theme.
Reply
GUEST
Nicole Udsen Luis

(modified: )

More studies are needed as to outcomes of respiratory support in early respiratory distress. Use of CPAP seems to reduce time of O2 dependence and discomfort, but may delay initiation of oral feeds. Studies should review time to discharge and complications. At our service we use early CPAP in term and preterm infants.
Reply
GUEST
LEONARDO SIQUEIRA

(modified: )

At my job we use CPAP after the birth at delivery room when necessary: moderate respiratory distress with grunting.
Reply
GUEST
Camilla Tovar

(modified: )

In our service, we use CPAP for all newborns over 34 weeks after resuscitation if there is no improvement after 2 h of mild respiratory distress or immediately after delivery in cases of more severe discomfort, in an attempt to avoid a more invasive intervention. Starting CPAP right after resuscitation, while still in the delivery room, for all NB > 34 weeks with respiratory distress can speed up the recovery process and start oral feeding, reducing hospital stay! More studies are needed to assess the risk of air leak syndrome!
Reply
GUEST
Nadia Sandra Orozco Vargas

(modified: )

I loved!!! Go ahead!!!
Reply
GUEST
Roque Antonio Foresti

(modified: )

We have not carried out controlled studies on whether or not to apply CPAP in the delivery room, but it is our usual practice. We don't use bells anymore. Only early CPAP, always as early as possible. We understand it as an effective practice.
Reply
GUEST
Gabriel Variane

(modified: )

That's a very interesting discussion. Previous studies have looked at the benefits of using CPAP in the delivery room for preterm infants, but there is still a lack of evidence of the real benefits of CPAP in the delivery room for spontaneously breathing late preterm and term newborn infants with respiratory distress. We routinely use early CPAP in our center for both term and preterm infants with respiratory distress.
Reply
GUEST
Murray Hinder

(modified: )

Design of device used to provide CPAP may be an important consideration when providing treatment to term infants. Bench testing of TPR devices show that high expiratory resistance of the CPAP/PEEP valve can contribute to incomplete expiration (autoPEEP) during PPV(1-3) and increased work of breathing during CPAP (4, 5) with near term and term lung compliances. RCT’s cited in Consensus of Science statement use devices with high expiratory resistance to provide CPAP, (Smithhart 2019 e20190756 Neopuff TPR) and (Hishikawa 2015 F382; Hishikawa 2016 Mercury Medical Hyper Inflation system with flow restrictor) (personal communication Dr Hishikawa 2016). More research on device suitability for provision of CPAP for term infants is needed. 1. Drevhammar T, Falk M, Donaldsson S, Tracy M, Hinder M. Neonatal Resuscitation With T-Piece Systems: Risk of Inadvertent PEEP Related to Mechanical Properties. Front Pediatr. 2021;9:663249. 2. Hinder M, McEwan A, Drevhammer T, Donaldson S, Tracy MB. T-piece resuscitators: how do they compare? Arch Dis Child Fetal Neonatal Ed. 2019;104(2):F122-F7. 3. Hinder M, Jani P, Priyadarshi A, McEwan A, Tracy M. Neopuff T-piece resuscitator: does device design affect delivered ventilation? Arch Dis Child Fetal Neonatal Ed. 2017;102(3):F220-F4. 4. Drevhammar T, Nilsson K, Zetterstrom H, Jonsson B. Comparison of seven infant continuous positive airway pressure systems using simulated neonatal breathing. PediatrCrit Care Med. 2012;13(2):e113-e9. 5. Donaldsson S, Drevhammar T, Taittonen L, Klemming S, Jonsson B. Initial stabilisation of preterm infants: a new resuscitation system with low imposed work of breathing for use with face mask or nasal prongs. Arch Dis Child Fetal Neonatal Ed. 2017;102(3):F203-F7.
Reply
GUEST
Janine Figueiredo

(modified: )

I am for the use of nCPAP in the delivery room, because I believe it not only helps the stabilization of the premature baby who is going to be admitted in the NICU (postponing or avoiding intubation to mechanical ventilation) but also helps the term and late preterm baby to go through cardiovascular adaptation, avoiding unnecessary NICU admissions.
Reply
GUEST
Helenilce Costa

(modified: )

Para o RN de termo usualmente não usamos CPAP precoce durante a reanimação na sala de parto.
Reply
GUEST
Marcos Silva

(modified: )

The use of early cpap in the delivery room has reduced the permanence of newborns in the ICU, there is still resistance on the part of professionals to use cpap in children under 1000 grams, but if this group is born vigorous and placed in cpap, maintain stable saturation levels (88-94) and heart rate above 100bpm, it is important to keep them on cpap even with moderate respiratory distress. However, further studies are needed to prove the benefit of early cpap in this group.
Reply
GUEST
MARINA CARVALHO DE MORAES BARROS

(modified: )

I agree with the use of CPAP in preterm infants with respiratory distress after birth, aiming at alveolar recruitment and in term neonates, since it favors the reabsorption of pulmonary fluid, a frequent cause of respiratory distress in these newborns.
Reply
GUEST
claire theyskens

(modified: )

So resp distress, better starts NCPAP in term and preterm
Reply
GUEST
Jose Perez

(modified: )

Guess the question is : can CPAP in the delivery room be harmful? In the preterm population at risk of inadequate spontaneous FRC and RDS, feel the risk/benefit ratio is low. I have read recent publications CPAP was very effective for TTNB so C/S delivery without labor, CPAP support also seems a reasonable approach. Unfortunately, TTNB is diagnosis of exclusion. In term infants with only mild distress or suboptimal target spo2, it seems reasonable to start with NC and take to transitional area. The risk CPAP may be harmful seems higher for these infants.
Reply
GUEST
Steve Gwiazdowski

(modified: )

I think this is a VERY sagacious opinion. The time constants driving pulonary pathology in preterm infants (many having RDS) should never have been extrapolated to term infants. The law of LaPlace governing oreterm infants with atelectasis often does call for CPAP for recruitment however, in term infants, respiratory distress does not always equate to FRC loss. A great example being meconium aspiration. CPAP should be witheld in term infants with respiratory distress unless 100% blow by oxygen cannot raise saturations to a safe level. A CXR is the prudent way to go prior to instition of positive pressure in these infants
Reply
GUEST
Carmen Elias

(modified: )

The practice of using CPAP in the delivery room should be more widespread, we know its benefits. In my opinion, what is lacking is the dissemination of good results, especially in premature babies.
Reply
GUEST
alessa mantovan

(modified: )

I agree with the Cpap in delivery room for both cases pre term and term specially in hospitals where we don’t have enough space in NICU. Of course we need to prepare our team to avoid the risks but in my reality earlier Cpap helps a lot!
Reply
GUEST
Patricia Mendes

(modified: )

I agree with the use of CPAP at the deliver room, so in preterm NB as in term NB. It helps to reduce respiratory distress.
Reply
GUEST
Natália Silva

(modified: )

In our service we use CPAP in term and preterm patients when necessary. This apparently reduces the time of observation of the newborn in the delivery room and the need for admissions to the NICU, considering that there is often a lack of available intensive care places. Complications attributed to the use of CPAP rarely occur. However, they are very valid questions for study.
Reply
GUEST
Mônica Teixeira

(modified: )

2) I believe that CPAP for term neonates may be beneficial for respiratory distress and might reduce time in the oxigentherapy.
Reply
GUEST
Racire Silva

(modified: )

CPAP in the delivery room avoids many hospitalizations in a NICU, makes us achieve skin-to-skin contact and breastfeeding in the first hour. It is fundamental!
Reply
GUEST
MARIA ALBERTINA REGO

(modified: )

In countries such as Brazil, with a high absolute number and proportion of preterm newborns greater than 34 weeks and full-term newborns, with variations in the quality of care offered in prenatal care and childbirth care, it is reasonable start CPAP and follow the clinical course integrated with the perinatal history, for spontaneously breathing newborns. The stabilization in great proportion of these neonates prevent from getting worse or even dying before transportation to a neonatal unit of greater level of care and from excess of mechanical ventilation.
Reply
GUEST
Nadir Gomes de Barros Santos

(modified: )

Used when the newborn has moderate respiratory distress for 1 hour. If the distress persists he is send to the ICU.
Reply
GUEST
José Roberto Ramos

(modified: )

I believe that the literature reviews do not have enough data for analysis of subgroups such as late preterm, cesarean delivery, facial mask or prongs. The rationale is that newborns with respiratory distress benefit from CPAP and the earlier its use seems to have greater benefit. At the moment we used Cpap for all with respiratory distress in the delivery room.
Reply
GUEST
Carmen Silvia Matimbianco de Figueiredo

(modified: )

The use of early cpap in the delivery room, in newborns that shows spontaneously breath - term/ late preterm and preterm - with mild or moderate distress has been used in our hospital, but we is still resistance on the part of professionals. Cpap in this case may help alveolar recruitment, cardiovascular adaptation, avoid intubation, helps to reduce ICU admissions. There is some questions that need more studies as incidence of Air Leak Syndrome. Whem applied, we observed satisfactory evolution of respiratory discomfort, less time of O2 use, but we have no controled trial to support our observations.
Reply
GUEST
Belize Barreto

(modified: )

We use cpap (with peep 6) at birth room if it’s necessary, moderaste distress term newborns . Or peep if extreme preterm with mild distress
Reply
GUEST
Shamya Rached Bandeira

(modified: )

I have been using CPAP in the delivery room for preterm infants, including preterm infants over 34 weeks, and I have noticed that there has been a reduction in respiratory distress rates and admission to intermediate care units.
Reply
GUEST
Terri Cavaliere

(modified: )

I am in agreement with the call for further investigation before recommending the use of CPAP in term newborns with respiratory distress.
Reply

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