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High-Flow Nasal Cannula Versus Nasal CPAP as Primary Support in Preterm Respiratory Distress Syndrome

3. juli 2026 oppdatert av: Kayseri City Hospital

Heated Humidified High-Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure as Primary Respiratory Support in Preterm Infants With Respiratory Distress Syndrome: A Randomized Controlled Trial

This single-center randomized controlled trial compared heated humidified high-flow nasal cannula (HHHFNC) with nasal continuous positive airway pressure (nCPAP) as primary noninvasive respiratory support in preterm infants (gestational age 28-34 weeks; birth weight 1000-2000 g) with moderate respiratory distress syndrome. The primary outcome was treatment failure requiring invasive mechanical ventilation within the first 7 days.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Eighty-six infants were randomized 1:1 to HHHFNC (n=43) or nCPAP (n=43). Both arms followed identical surfactant, escalation, and weaning protocols. Outcomes included treatment failure, nasal trauma, sepsis, feeding intolerance, and time to full enteral feeding.

Studietype

Intervensjonell

Registrering (Faktiske)

86

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
    • Kayseri
      • Kayseri, Kayseri, Tyrkia (Türkiye), 38090
        • Kayseri City Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

Preterm infants admitted to the NICU who fulfilled all of the following were eligible:

  1. Gestational age (GA) 28+0 to 34+6 weeks and/or birth weight 1,000-2,000 g
  2. Clinical and radiological diagnosis of moderate respiratory distress syndrome (RDS)
  3. Silverman-Anderson score (SAS) 4 < SAS < 7
  4. Eligibility for noninvasive ventilatory support

Exclusion Criteria:

  1. Parental refusal of consent
  2. Outborn infants transferred from other centers
  3. Infants who required immediate intubation in the delivery room
  4. Major congenital anomalies, chromosomal disorders, gastrointestinal malformations, or life-threatening congenital cardiac defects
  5. Nasal/pharyngeal anatomical anomalies (choanal atresia, cleft palate/lip)
  6. Moderate-to-severe hypoxic-ischemic encephalopathy (Grade 2-3)
  7. Infants who died unexpectedly shortly after admission without respiratory evaluation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group 1 Heated humidified high-flow nasal cannula (HHHFNC)
n:43 Vapotherm Precision Flow Hi-VNI; initial flow 5 L/min (range 5-8 L/min), 37°C, 100% humidity; FiO₂ titrated to SpO₂ 91-95%.
Enhet: Group 1 Heated humidified high-flow nasal cannula (HHHFNC)
HHHFNC delivered via the Vapotherm Precision Flow Hi-VNI system; initial flow 5 L/min (range 5-8 L/min), 37°C, 100% humidity; FiO2 titrated to maintain SpO2 91-95%.
Andre navn:
  • Vapotherm Precision Flow Hi-VNI
Aktiv komparator: Group 2 Nasal continuous positive airway pressure (nCPAP)
n:43 nCPAP via ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to SpO2 91-95%.
Enhet: Group 2 Nasal continuous positive airway pressure (nCPAP)
nCPAP delivered via a ventilator-driven system; pressure 5-8 cmH2O; FiO2 titrated to maintain SpO2 91-95%.
Andre navn:
  • nCPAP

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Treatment Failure Requiring Invasive Mechanical Ventilation
Tidsramme: First 7 days of life (assessed at 72 hours, Day 5, and Day 7)
Treatment failure defined as the need for invasive mechanical ventilation per pre-specified criteria (FiO2 >=0.60 to maintain SpO2 91-95%; pH <7.20 with PaCO2 >60 mmHg; recurrent or caffeine-refractory apnea; markedly increased work of breathing; or clinical deterioration determined by the attending neonatologist), assessed at 72 hours, Day 5, and Day 7 of life.
First 7 days of life (assessed at 72 hours, Day 5, and Day 7)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Nasal Trauma
Tidsramme: During noninvasive respiratory support (first 7 days of life)
Nasal trauma defined as redness, excoriation, bleeding, or crusting at the nasal septum or nares attributed to the respiratory support interface.
During noninvasive respiratory support (first 7 days of life)
Number of Participants With Proven (Culture-Positive) Late-Onset Sepsis
Tidsramme: From 72 hours of life through hospital discharge, an average of 24 days
Culture-positive late-onset sepsis with onset after 72 hours of life.
From 72 hours of life through hospital discharge, an average of 24 days
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Tidsramme: At 36 weeks postmenstrual age
BPD defined as an oxygen requirement at 36 weeks postmenstrual age.
At 36 weeks postmenstrual age

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Patent Ductus Arteriosus (PDA) Requiring Treatment
Tidsramme: From randomization through hospital discharge, an average of 24 days
PDA requiring medical or surgical treatment.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Intraventricular Hemorrhage (IVH) of Any Grade
Tidsramme: From randomization through hospital discharge, an average of 24 days
IVH of any grade detected on cranial ultrasound.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Necrotizing Enterocolitis (NEC) of Any Stage
Tidsramme: From randomization through hospital discharge, an average of 24 days
NEC of any stage.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Retinopathy of Prematurity (ROP)
Tidsramme: From randomization through hospital discharge, an average of 24 days
ROP of any stage on ophthalmologic examination.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Periventricular Leukomalacia (PVL)
Tidsramme: From randomization through hospital discharge, an average of 24 days
PVL detected on cranial imaging.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Feeding Intolerance
Tidsramme: From randomization through hospital discharge, an average of 24 days
Feeding intolerance per pre-specified clinical criteria.
From randomization through hospital discharge, an average of 24 days
Days to Full Enteral Feeding
Tidsramme: From birth until full enteral feeding is achieved, an average of 8 days
Number of days from birth to achievement of full enteral feeding (>=120 mL/kg/day).
From birth until full enteral feeding is achieved, an average of 8 days
Duration of Total Parenteral Nutrition (TPN)
Tidsramme: From birth through hospital discharge, an average of 24 days
Total duration of parenteral nutrition, in days.
From birth through hospital discharge, an average of 24 days
Duration of Total Oxygen Support
Tidsramme: From randomization through hospital discharge, an average of 24 days
Total duration of any oxygen support, in days.
From randomization through hospital discharge, an average of 24 days
Number of Participants With All-Cause In-Hospital Mortality
Tidsramme: From randomization through hospital discharge, an average of 24 days
All-cause mortality during hospitalization.
From randomization through hospital discharge, an average of 24 days
Number of Participants With Air Leak Syndrome
Tidsramme: First 7 days of life (respiratory support period)
Air leak syndrome, including pneumothorax.
First 7 days of life (respiratory support period)
Number of Participants With Clinically Significant Apnea
Tidsramme: First 7 days of life (respiratory support period)
Clinically significant apnea episodes.
First 7 days of life (respiratory support period)
Discharge Weight
Tidsramme: At hospital discharge, an average of 24 days after randomization
Body weight at hospital discharge, in grams.
At hospital discharge, an average of 24 days after randomization
Hospital Length of Stay
Tidsramme: From randomization through hospital discharge, an average of 24 days
Total length of hospital stay, in days.
From randomization through hospital discharge, an average of 24 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kayseri City Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2020

Primær fullføring (Faktiske)

1. mai 2022

Studiet fullført (Faktiske)

1. mai 2022

Datoer for studieregistrering

Først innsendt

16. juni 2026

Først innsendt som oppfylte QC-kriteriene

3. juli 2026

Først lagt ut (Faktiske)

9. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Ethics C.D.No:141(Kayseri CH)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

The data that support the findings of this study are not publicly available due to privacy and ethical restrictions but are available from the corresponding author upon reasonable request.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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