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Not yet recruitingNCT06683677SIMPLSAFE2Updated Nov 14, 2024

High Flow Nasal Cannula for Stabilization of Extremely Premature Infants

An interventional study of High-Flow Nasal Cannula in Premature Infant, Ventilation Therapy and High Flow Nasal Canula, sponsored by Charles University, Czech Republic. Not yet recruiting at 1 site in Czechia. Open to participants aged 0 Minutes to 2 Minutes. Per ClinicalTrials.gov, last updated 2024-11-14.

Sponsored by Charles University, Czech Republic · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
0 Minutes to 2 Minutes
Sex
All
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Study summary

A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize extremely preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 6-8 l/min is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low Saturation of oxygen (SpO2).

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Conditions studied

  • Premature Infant
  • Ventilation Therapy
  • High Flow Nasal Canula

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03

In context

Premature Birth

2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.

This study's planned enrollment of 60 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 227 studies on the registry; 76 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Minutes to 2 Minutes
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Preterm infants born between 25+0 and 27+6 gestational weeks
  • Weight above 500 grams

Exclusion criteria

Exclusion Criteria:

  • Previable rupture of membranes,
  • Congenital malformations previable
  • Acute intrauterine hypoxia.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    High-flow-nasal-cannula

    Extremely preterm infants receive High-Flow Nasal Cannula therapy immediately after birth. The intervention includes placental transfusion, followed by administering High-Flow Nasal Cannula at a flow rate of 8 l/min along with intermittent tactile stimulation. Criteria for switching to Continuous Positive Airway Pressure or Positive Pressure Ventilation are established for cases of persistent bradycardia or low Saturation of oxygen (SpO2).

    Device: High-Flow Nasal Cannula

Interventions

  • DeviceHigh-Flow Nasal Cannula

    The intervention involves administering High-Flow Nasal Cannula therapy to extremely preterm infants immediately after birth.

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What researchers measure

Primary outcomes

  1. Positive pressure ventilation after delivery

    The number of infants who required positive pressure ventilation (PPV) in the first ten minutes after delivery.

    Time frame: 10 minutes

Secondary outcomes

  1. SpO₂ > 80% in five minutes after delivery

    The number of infants with SpO₂ \> 80% five minutes after delivery, with or without the use of positive pressure ventilation (PPV).

    Time frame: 5 minutes

  2. SpO₂ > 90% ten minutes after delivery

    The number of infants with SpO₂ \> 90% ten minutes after delivery without the use of positive pressure ventilation (PPV).

    Time frame: 10 minutes

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Study locations

1 site
  • General University Hospital Prague
    Prague, Prague 12000, Czechia
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References and documents

Publications

  • Manley BJ, Arnolda GRB, Wright IMR, Owen LS, Foster JP, Huang L, Roberts CT, Clark TL, Fan WQ, Fang AYW, Marshall IR, Pszczola RJ, Davis PG, Buckmaster AG; HUNTER Trial Investigators. Nasal High-Flow Therapy for Newborn Infants in Special Care Nurseries. N Engl J Med. 2019 May 23;380(21):2031-2040. doi: 10.1056/NEJMoa1812077. PubMed 31116919 ↗
  • Roberts CT, Owen LS, Manley BJ, Froisland DH, Donath SM, Dalziel KM, Pritchard MA, Cartwright DW, Collins CL, Malhotra A, Davis PG; HIPSTER Trial Investigators. Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants. N Engl J Med. 2016 Sep 22;375(12):1142-51. doi: 10.1056/NEJMoa1603694. PubMed 27653564 ↗
  • Bjorland PA, Oymar K, Ersdal HL, Rettedal SI. Incidence of newborn resuscitative interventions at birth and short-term outcomes: a regional population-based study. BMJ Paediatr Open. 2019 Dec 29;3(1):e000592. doi: 10.1136/bmjpo-2019-000592. eCollection 2019. PubMed 31909225 ↗
  • Norman E, Westrin P, Fellman V. Placental transfer and pharmacokinetics of thiopentone in newborn infants. Arch Dis Child Fetal Neonatal Ed. 2010 Jul;95(4):F277-82. doi: 10.1136/adc.2009.177626. Epub 2010 May 20. PubMed 20488867 ↗
  • Tana M, Tirone C, Aurilia C, Lio A, Paladini A, Fattore S, Esposito A, De Tomaso D, Vento G. Respiratory Management of the Preterm Infant: Supporting Evidence-Based Practice at the Bedside. Children (Basel). 2023 Mar 10;10(3):535. doi: 10.3390/children10030535. PubMed 36980093 ↗
  • Diggikar S, Ramaswamy VV, Koo J, Prasath A, Schmolzer GM. Positive Pressure Ventilation in Preterm Infants in the Delivery Room: A Review of Current Practices, Challenges, and Emerging Technologies. Neonatology. 2024;121(3):288-297. doi: 10.1159/000537800. Epub 2024 Mar 11. PubMed 38467119 ↗
  • Foglia EE, Shah BA, Szyld E. Positive pressure ventilation at birth. Semin Perinatol. 2022 Oct;46(6):151623. doi: 10.1016/j.semperi.2022.151623. Epub 2022 May 21. PubMed 35697527 ↗
  • Roehr CC, Yoder BA, Davis PG, Ives K. Evidence Support and Guidelines for Using Heated, Humidified, High-Flow Nasal Cannulae in Neonatology: Oxford Nasal High-Flow Therapy Meeting, 2015. Clin Perinatol. 2016 Dec;43(4):693-705. doi: 10.1016/j.clp.2016.07.006. PubMed 27837753 ↗
  • Mazmanyan P, Darakchyan M, Pinkham MI, Tatkov S. Mechanisms of nasal high flow therapy in newborns. J Appl Physiol (1985). 2020 Apr 1;128(4):822-829. doi: 10.1152/japplphysiol.00871.2019. Epub 2020 Feb 20. PubMed 32078463 ↗
  • Roberts CT, Hodgson KA. Nasal high flow treatment in preterm infants. Matern Health Neonatol Perinatol. 2017 Sep 6;3:15. doi: 10.1186/s40748-017-0056-y. eCollection 2017. PubMed 28904810 ↗
  • Siva NV, Reynolds PR. Stabilisation of the preterm infant in the delivery room using nasal high flow: A 5-year retrospective analysis. Acta Paediatr. 2021 Jul;110(7):2065-2071. doi: 10.1111/apa.15824. Epub 2021 Mar 8. PubMed 33638878 ↗
  • Reynolds P, Leontiadi S, Lawson T, Otunla T, Ejiwumi O, Holland N. Stabilisation of premature infants in the delivery room with nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F284-7. doi: 10.1136/archdischild-2015-309442. Epub 2016 Jan 5. PubMed 26733541 ↗
  • Kuypers KLAM, Hopman A, Cramer SJE, Dekker J, Visser R, Hooper SB, Te Pas AB. Effect of initial and subsequent mask applications on breathing and heart rate in preterm infants at birth. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):594-598. doi: 10.1136/archdischild-2022-324835. Epub 2023 Apr 20. PubMed 37080734 ↗
  • Kuypers K, Martherus T, Lamberska T, Dekker J, Hooper SB, Te Pas AB. Reflexes that impact spontaneous breathing of preterm infants at birth: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):675-679. doi: 10.1136/archdischild-2020-318915. Epub 2020 Apr 29. PubMed 32350064 ↗
  • Martherus T, Oberthuer A, Dekker J, Hooper SB, McGillick EV, Kribs A, Te Pas AB. Supporting breathing of preterm infants at birth: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2019 Jan;104(1):F102-F107. doi: 10.1136/archdischild-2018-314898. Epub 2018 Jul 26. PubMed 30049727 ↗
  • Lista G, Cavigioli F, La Verde PA, Castoldi F, Bresesti I, Morley CJ. Effects of Breathing and Apnoea during Sustained Inflations in Resuscitation of Preterm Infants. Neonatology. 2017;111(4):360-366. doi: 10.1159/000454799. Epub 2017 Jan 25. PubMed 28118641 ↗
  • Kirpalani H, Ratcliffe SJ, Keszler M, Davis PG, Foglia EE, Te Pas A, Fernando M, Chaudhary A, Localio R, van Kaam AH, Onland W, Owen LS, Schmolzer GM, Katheria A, Hummler H, Lista G, Abbasi S, Klotz D, Simma B, Nadkarni V, Poulain FR, Donn SM, Kim HS, Park WS, Cadet C, Kong JY, Smith A, Guillen U, Liley HG, Hopper AO, Tamura M; SAIL Site Investigators. Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial. JAMA. 2019 Mar 26;321(12):1165-1175. doi: 10.1001/jama.2019.1660. PubMed 30912836 ↗
  • Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24. PubMed 33773829 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06683677
Lead sponsor
Charles University, Czech Republic
Responsible party
Jonáš Klára (Principal Investigator, Charles University, Czech Republic) — Principal investigator
First posted
Nov 12, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Jul 1, 2029 (estimated)
Last update
Nov 14, 2024

Study contacts

Klára Jonáš
Contact
klara.jonas@vfn.cz
00420602504067
Richard Plavka
Contact
Richard.Plavka@vfn.cz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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