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Not yet recruiting NCT06683677

High Flow Nasal Cannula for Stabilization of Extremely Premature Infants

No phase Interventional Premature Infant Ventilation Therapy High Flow Nasal Canula

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-Flow Nasal Cannula.
Who it may be relevant to
Registry conditions: Premature Infant, Ventilation Therapy, High Flow Nasal Canula. Basic parameters: 0 Minutes — 2 Minutes · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Positive pressure ventilation after delivery [Time frame: 10 minutes]
Secondary outcome measures (2)
  • SpO₂ > 80% in five minutes after delivery [Time frame: 5 minutes]
  • SpO₂ > 90% ten minutes after delivery [Time frame: 10 minutes]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Czechia · 1 center
  • General University Hospital Prague — Prague

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 27837753

Identifiers

NCT: NCT06683677 · 16/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗