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Premature InfantSIMPLSAFE2NCT06683677

High Flow Nasal Cannula for Stabilization of Extremely Premature Infants

A study testing High-Flow Nasal Cannula in people with Premature Infant and Ventilation Therapy, run by Charles University, Czech Republic at 1 site in Czechia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 0 to 2 minutes
What is being tested?
High-Flow Nasal Cannula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCzechia
Study dates
1 Dec 2024to 1 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 2 minutes
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Klára Jonáš contact

00420602504067

klara.jonas@vfn.cz

Richard Plavka contact

Richard.Plavka@vfn.cz

Czechia1 site

  • General University Hospital Prague

    Prague, Prague, 12000

Other trials in Czechia

About this study

Official title: High Flow Nasal Cannula is Appropriate Alternative for Stabilization of Extremely Premature Infants: a Prospective Observational Study

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).

Being tested
High-Flow Nasal Cannula
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Flow Nasal CannulaDevice

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

Study groups in NCT06683677
Study groupRoleWhat they receive
High-flow-nasal-cannulaExperimentalExtremely 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).
Receives: Device: High-Flow Nasal Cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive pressure ventilation after delivery

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

    Measured: 10 minutes

Secondary outcomes (2)

  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).

    Measured: 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).

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start1 Dec 2024 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06683677
Sponsor's protocol ID
16/24
Acronym
SIMPLSAFE2
Status last verified
Nov 2024
First submitted
8 Nov 2024
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing High-Flow Nasal Cannula in people with Premature Infant and Ventilation Therapy, run by Charles University, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Klára Jonáš (00420602504067, klara.jonas@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive pressure ventilation after delivery (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06683677, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.

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