NCT06683677

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
39mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Dec 2024Jul 2029

First Submitted

Initial submission to the registry

November 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

4.1 years

First QC Date

November 8, 2024

Last Update Submit

November 12, 2024

Conditions

Premature InfantVentilation TherapyHigh Flow Nasal Canula

Outcome Measures

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.

    10 minutes

Secondary Outcomes (2)

  • SpO₂ > 80% in five minutes after delivery

    5 minutes

  • SpO₂ > 90% ten minutes after delivery

    10 minutes

Study Arms (1)

High-flow-nasal-cannula

EXPERIMENTAL

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

High-Flow Nasal CannulaDEVICE

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

High-flow-nasal-cannula

Eligibility Criteria

Age0 Minutes - 2 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General University Hospital Prague

Prague, Prague, 12000, Czechia

Location

Related Publications (18)

  • 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.

    PMID: 31116919BACKGROUND

  • 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.

    PMID: 27653564BACKGROUND

  • 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.

    PMID: 31909225BACKGROUND

  • 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.

    PMID: 20488867BACKGROUND

  • 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.

    PMID: 36980093BACKGROUND

  • 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.

    PMID: 38467119BACKGROUND

  • 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.

    PMID: 35697527BACKGROUND

  • 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.

    PMID: 27837753BACKGROUND

  • 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.

    PMID: 32078463BACKGROUND

  • 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.

    PMID: 28904810BACKGROUND

  • 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.

    PMID: 33638878BACKGROUND

  • 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.

    PMID: 26733541BACKGROUND

  • 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.

    PMID: 37080734BACKGROUND

  • 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.

    PMID: 32350064BACKGROUND

  • 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.

    PMID: 30049727BACKGROUND

  • 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.

    PMID: 28118641BACKGROUND

  • 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.

    PMID: 30912836BACKGROUND

  • 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.

    PMID: 33773829BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Klára Jonáš

CONTACT

00420602504067klara.jonas@vfn.cz

Richard Plavka

CONTACT

Richard.Plavka@vfn.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 12, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

November 14, 2024

Record last verified: 2024-11

Locations

CZ(1)