Skip to main content
SpringerLink
Log in

T-Piece resuscitator versus self-inflating bag for delivery room resuscitation in preterm neonates: a randomized controlled trial

  • RESEARCH
  • Published:
European Journal of Pediatrics Aims and scope Submit manuscript

Abstract

The establishment of adequate ventilation is the cornerstone of neonatal resuscitation in the delivery room (DR). This parallel-group, accessor-blinded randomized controlled trial compared the changes in peripheral oxygen saturation (SpO2), heart rate (HR), and cerebral regional oxygen saturation (crSO2) with the use of a T-piece resuscitator (TPR) versus self-inflating bag (SIB) as a mode of providing positive pressure ventilation (PPV) during DR resuscitation in preterm neonates. Seventy-two preterm neonates were randomly allocated to receive PPV with TPR (n = 36) or SIB (n = 36). The primary outcome was SpO2 (%) at 5 min. The secondary outcomes included the time to achieve a SpO2 ≥ 80% and > 85%, HR > 100/min, fractional-inspired oxygen (FiO2) requirement, minute-specific SpO2, HR and FiO2 trends for the first 5 min of life, need for DR-intubation, crSO2, need and duration of respiratory support, and other in-hospital morbidities. Mean SpO2 at 5 min was 74.5 ± 17.8% and 69.4 ± 22.4%, in TPR and SIB groups, respectively [Mean difference, 95% Confidence Interval 5.08 (-4.41, 14.58); p = 0.289]. No difference was observed in the time to achieve a SpO2 ≥ 80% and > 85%, HR > 100/min, the requirement of FiO2, DR-intubation, and the need and duration of respiratory support. There was no significant difference in the minute-specific SpO2, HR, and FiO2 requirements for the first 5 min. CrSO2 (%) at one hour was lower by 5% in the TPR group compared to SIB; p = 0.03. Other complications were comparable.

Conclusions: TPR and SIB resulted in comparable SpO2 at 5 min along with similar minute-specific SpO2, HR, and FiO2 trends.

Clinical Trial Registration: Clinical trial registry of India, Registration no: CTRI/2021/10/037384, Registered prospectively on: 20/10/2021, https://ctri.icmr.org.in/.

What is Known:

• Compared to self-inflating bags (SIB), T-piece resuscitators (TPR) provide more consistent inflation pressure and tidal volume as shown in animal and bench studies.

• There is no strong recommendation for one device over the other in view of low certainty evidence.

What is New:

• TPR and SIB resulted in comparable peripheral oxygen saturation (SpO2) at 5 min along with similar minute-specific SpO2, heart rate, and fractional-inspired oxygen requirement trends.

• Short-term complications and mortality rates were comparable with both devices.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

Availability of data and material

Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to: bhrajishna@gmail.com.

Code availability

N/A.

Abbreviations

DR:

Delivery room

PPV:

Positive pressure ventilation

GA:

Gestational age

SIB:

Self-inflating bag

FIB:

Flow-inflating bag

TPR:

T-piece resuscitator

PIP:

Peak inspiratory pressure

VT :

Tidal volume

PEEP:

Positive end-expiratory pressure

SpO2 :

Peripheral oxygen saturation

HR:

Heart rate

IVH:

Intraventricular hemorrhage

CrSO2 :

Cerebral regional oxygen saturation

RCT:

Randomized controlled trial

CTRI:

Clinical Trial Registry of India

AHA-NRP:

American Heart Association-Neonatal Resuscitation Program

FiO2 :

Fractional inspired oxygen

NIRS:

Near-infrared spectroscopy

MAP:

Mean arterial pressure

hs-PDA:

Hemodynamically significant patent ductus arteriosus

NEC:

Necrotizing enterocolitis

SIP:

Spontaneous intestinal perforation

PVL:

Periventricular leukomalacia

ROP:

Retinopathy of prematurity

BPD:

Bronchopulmonary dysplasia

NICU:

Neonatal intensive care unit

SD:

Standard deviation

ITT:

Intention to treat

IQR:

Interquartile range

MD:

Mean difference

CI:

Confidence interval

RR:

Risk Ratio

OR:

Odds ratio

References

  1. Aziz K, Lee CHC, Escobedo MB, Hoover AV, Kamath-Rayne BD, Kapadia VS et al (2021) Part 5: Neonatal Resuscitation 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Pediatrics 147:e2020038505E. https://doi.org/10.1542/peds.2020-038505E

    Article  PubMed  Google Scholar 

  2. Ersdal HL, Mduma E, Svensen E, Perlman JM (2012) Early initiation of basic resuscitation interventions including face mask ventilation may reduce birth asphyxia related mortality in low-income countries: a prospective descriptive observational study. Resuscitation 83:869–873. https://doi.org/10.1016/j.resuscitation.2011.12.011

    Article  PubMed  Google Scholar 

  3. Bjorland PA, Øymar K, Ersdal HL, Rettedal SI (2019) Incidence of newborn resuscitative interventions at birth and short-term outcomes: a regional population-based study. BMJ Paediatr Open 3:e000592. https://doi.org/10.1136/bmjpo-2019-000592

    Article  PubMed  PubMed Central  Google Scholar 

  4. Niles DE, Cines C, Insley E, Foglia EE, Elci OU, Skåre C et al (2017) Incidence and characteristics of positive pressure ventilation delivered to newborns in a US tertiary academic hospital. Resuscitation 115:102–109. https://doi.org/10.1016/j.resuscitation.2017.03.035

    Article  PubMed  Google Scholar 

  5. Roehr CC, O’Shea JE, Dawson JA, Wyllie JP (2018) Devices used for stabilisation of newborn infants at birth. Arch Dis Child Fetal Neonatal Ed 103:F66-71. https://doi.org/10.1136/archdischild-2016-310797

    Article  PubMed  Google Scholar 

  6. Tracy MB, Halliday R, Tracy SK, Hinder MK (2019) Newborn self-inflating manual resuscitators: precision robotic testing of safety and reliability. Arch Dis Child Fetal Neonatal Ed 104:F403–F408. https://doi.org/10.1136/archdischild-2018-315391

    Article  PubMed  Google Scholar 

  7. Hinder M, McEwan A, Drevhammer T, Donaldson S, Tracy MB (2019) T-piece resuscitators: how do they compare? Arch Dis Child Fetal Neonatal Ed 104:F122–F127. https://doi.org/10.1136/archdischild-2018-314860

    Article  PubMed  Google Scholar 

  8. Rafferty AR, Johnson L, Maxfield D, Dawson JA, Davis PG, Thio M (2016) The accuracy of delivery of target pressures using self-inflating bag manometers in a benchtop study. Acta Paediatr 105:e247–e251. https://doi.org/10.1111/apa.13397

    Article  PubMed  Google Scholar 

  9. Hartung JC, Dold SK, Thio M, tePas A, Schmalisch G, Roehr CC (2014) Time to adjust to changes in ventilation settings varies significantly between different T-piece resuscitators, self-inflating bags, and manometer equipped self-inflating bags. Am J Perinatol 31:505–512. https://doi.org/10.1055/s-0033-1354562

    Article  PubMed  Google Scholar 

  10. Roehr CC, Kelm M, Fischer HS, Bührer C, Schmalisch G, Proquitté H (2010) Manual ventilation devices in neonatal resuscitation: tidal volume and positive pressure-provision. Resuscitation 81:202–205. https://doi.org/10.1016/j.resuscitation.2009.10.008

    Article  PubMed  Google Scholar 

  11. Hawkes CP, Ryan CA, Dempsey EM (2012) Comparison of the T-piece resuscitator with other neonatal manual ventilation devices: a qualitative review. Resuscitation 83:797–802. https://doi.org/10.1016/j.resuscitation.2011.12.020

    Article  PubMed  Google Scholar 

  12. Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres JW, Fawke J: Neonatal Life Support Collaborators, et al (2020) Neonatal Life Support 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Resuscitation 156:A156–A187. https://doi.org/10.1016/j.resuscitation.2020.09.015

    Article  PubMed  Google Scholar 

  13. Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rüdiger M et al (2021) European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation 161:291–326. https://doi.org/10.1016/j.resuscitation.2021.02.014

    Article  PubMed  Google Scholar 

  14. Katheria AC, Hassen K, Rich W, Poeltler D, Finer N (2019) Resuscitation outcomes of infants that do not achieve a 5 min target SpO2 saturation. J Perinatol 39:1635–1639. https://doi.org/10.1038/s41372-019-0491-x

    Article  CAS  PubMed  Google Scholar 

  15. Oei JL, Finer NN, Saugstad OD, Wright IM, Rabi Y, Tarnow-Mordi W et al (2018) Outcomes of oxygen saturation targeting during delivery room stabilisation of preterm infants. Arch Dis Child Fetal Neonatal Ed 103:F446–F454. https://doi.org/10.1136/archdischild-2016-312366

    Article  PubMed  Google Scholar 

  16. Dawson JA, Schmölzer GM, Kamlin CO, Te Pas AB, O'Donnell CP, Donath SM et al (2011) Oxygenation with T-piece versus self-inflating bag for ventilation of extremely preterm infants at birth: a randomized controlled trial. J Pediatr 158:912–8.e1–2. https://doi.org/10.1016/j.jpeds.2010.12.003

  17. Szyld E, Aguilar A, Musante GA, Vain N, Prudent L, Fabres J et al, Delivery Room Ventilation Devices Trial Group (2014) Comparison of devices for newborn ventilation in the delivery room. J Pediatr 165:234–239.e3. https://doi.org/10.1016/j.jpeds.2014.02.035

  18. Cimatti AG, Martini S, Galletti S, Vitali F, Aceti A, Frabboni G et al (2020) Cerebral Oxygenation and Autoregulation in Very Preterm Infants Developing IVH During the Transitional Period: A Pilot Study. Front Pediatr 8:381. https://doi.org/10.3389/fped.2020.00381

    Article  PubMed  PubMed Central  Google Scholar 

  19. Wolfsberger CH, Pichler-Stachl E, Höller N, Mileder LP, Schwaberger B, Avian A et al (2023) Cerebral oxygenation immediately after birth and long-term outcome in preterm neonates-a retrospective analysis. BMC Pediatr 23:145. https://doi.org/10.1186/s12887-023-03960-z

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  20. Schwaberger B, Pichler G, Binder C, Avian A, Pocivalnik M, Urlesberger B (2014) Even mild respiratory distress alters tissue oxygenation significantly in preterm infants during neonatal transition. Physiol Meas 35:2085–2099. https://doi.org/10.1088/0967-3334/35/10/2085

    Article  PubMed  Google Scholar 

  21. Mariani G, Dik PB, Ezquer A, Aguirre A, Esteban ML, Perez C et al (2007) Pre-ductal and post-ductal O2 saturation in healthy term neonates after birth. J Pediatr 150(4):418–421. https://doi.org/10.1016/j.jpeds.2006.12.015

    Article  PubMed  Google Scholar 

  22. Tribolet S, Hennuy N, Rigo V (2023) Ventilation devices for neonatal resuscitation at birth: A systematic review and meta-analysis. Resuscitation 183:109681. https://doi.org/10.1016/j.resuscitation.2022.109681

    Article  PubMed  Google Scholar 

  23. Trevisanuto D, Roehr CC, Davis PG, Schmölzer GM, Wyckoff MH, Liley HG: INTERNATIONAL LIAISON COMMITTEE ON RESUSCITATION NEONATAL LIFE SUPPORT TASK FORCE, et al (2021) Devices for Administering Ventilation at Birth: A Systematic Review. Pediatrics 148:e2021050174. https://doi.org/10.1542/peds.2021-050174

    Article  PubMed  Google Scholar 

  24. Bellos I, Pillai A, Pandita A (2022) Providing Positive End Expiratory Pressure during Neonatal Resuscitation: A Meta-analysis. Am J Perinatol. https://doi.org/10.1055/a-1933-7235

    Article  Google Scholar 

  25. Evans N, Kluckow M (1996) Early determinants of right and left ventricular output in ventilated preterm infants. Arch Dis Child Fetal Neonatal Ed 74:F88-94. https://doi.org/10.1136/fn.74.2.f88

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  26. Pichler G, Urlesberger B, Baik N, Schwaberger B, Binder-Heschl C, Avian A et al (2016) Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial. J Pediatr 170:73–8.e1–4. https://doi.org/10.1016/j.jpeds.2015.11.053

Download references

Acknowledgements

We would like to thank all the study infants and their families who accepted joining this study.

Funding

There is no external funding source.

Author information

Authors and Affiliations

  1. Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, 249203, India

    Bhrajishna Pallapothu, Mayank Priyadarshi, Poonam Singh, Sourabh Kumar, Suman Chaurasia & Sriparna Basu

Authors
  1. Bhrajishna Pallapothu
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Mayank Priyadarshi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Poonam Singh
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Sourabh Kumar
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Suman Chaurasia
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Sriparna Basu
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

S.B., B.P., M.P., P.S., S.K., and S.C.  conceptualized and designed the study, coordinated, and supervised data collection, drafted the initial manuscript, and reviewed and revised the manuscript. All authors reviewed and approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Sriparna Basu.

Ethics declarations

Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Institute Ethics Committee of All India Institute of Medical Sciences, Rishikesh, India (AIIMS/IEC/21/518, Dated 02/09/2021).

Consent for publication

Written informed consent was obtained from all the parents of the study participants for publication of their data.

Consent to participate

Written informed consent was obtained from all the parents of the study participants.

Competing interest

The research was not sponsored by any funding organization and none of the authors have any financial disclosure to make.

Additional information

Communicated by Daniele De Luca

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Pallapothu, B., Priyadarshi, M., Singh, P. et al. T-Piece resuscitator versus self-inflating bag for delivery room resuscitation in preterm neonates: a randomized controlled trial. Eur J Pediatr 182, 5565–5576 (2023). https://doi.org/10.1007/s00431-023-05230-7

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00431-023-05230-7

Keywords

Search

Navigation