NCT06458582

Brief Summary

A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize very preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 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 SpO2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

November 12, 2024

Status Verified

June 1, 2024

Enrollment Period

1.9 years

First QC Date

June 9, 2024

Last Update Submit

November 8, 2024

Conditions

Premature; Infant

Keywords

neonatologyHFNCprematurity

Outcome Measures

Primary Outcomes (1)

  • HFNC slabilization

    Number of infants who were stabilized after birth on high flow nasal cannula exclusively without any other use of artificial external pressures.

    10 minutes after delivery

Study Arms (1)

High-flow-nasal-cannula

EXPERIMENTAL

In this study, very 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 SpO2.

Device: High-Flow Nasal Cannula

Interventions

High-Flow Nasal CannulaDEVICE

The intervention involves administering High-Flow Nasal Cannula therapy to very 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 28+0 and 31+6 gestational weeks were enrolled in the study after obtaining parental informed consent.

You may not qualify if:

  • Infants with congenital malformations, previable rupture of membranes, and acute intrauterine hypoxia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles University in Prague

Prague, Czech, 12808, Czechia

Location

Related Publications (18)

  • 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

  • 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

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

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

June 9, 2024

First Posted

June 13, 2024

Study Start

February 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)