Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants
Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants After Birth: A Randomized Controlled Trial
Preterm infants frequently require non-invasive ventilation (NIV) to treat respiratory distress after birth. The effectiveness of NIV may be influenced by the interface used to deliver respiratory support. Nasal cannula and single nasal prong are two interfaces commonly used for NIV; however, evidence directly comparing their efficacy during the early postnatal period remains limited.
This randomized controlled trial aims to compare the efficacy of a nasal cannula and a single nasal prong as interfaces for non-invasive ventilation in preterm infants after birth. Eligible preterm infants requiring NIV after initial stabilization will be randomly assigned to receive respiratory support using either a nasal cannula or a single nasal prong. The assigned interface will be maintained for one hour following randomization, including during transport from the delivery room to the neonatal intensive care unit.
The primary outcome is the need for endotracheal intubation within one hour after interface application. Secondary outcomes include the need for endotracheal intubation within 6 hour of age, respiratory effectiveness, assessed by the oxygen saturation index (OSI) and arterial blood gas parameters (pH and partial pressure of carbon dioxide [pCO₂]), as well as interface-related adverse events, including interface dislodgement and nasal injury.
This study is expected to provide evidence to support the selection of an effective non-invasive ventilation interface for preterm infants after birth.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Raden Adhi Teguh Perma Iskandar, Principal Investigator
- Telefonnummer: 085779153162
- E-Mail: adhitpi@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Ina Rochayati
- Telefonnummer: 087712526805
- E-Mail: inarochayati@gmail.com
Studienorte
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonesien
- Rumah Sakit dr. Cipto Mangunkusumo
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Kontakt:
- Raden Adhi Teguh Perma Iskandar, Principal Investigator
- Telefonnummer: 085779153162
- E-Mail: adhitpi@gmail.com
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Kontakt:
- Rochayati Ina
- Telefonnummer: 087712526805
- E-Mail: inarochayati@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
Inclusion Criteria:
- Preterm infants with a gestational age of 28 to <37 weeks who develop respiratory distress and require non-invasive ventilation (NIV) after birth.
- Written informed consent is obtained from a parent or legal guardian.
Exclusion Criteria:
- Infants with congenital nasal defects, including cleft lip and palate.
- Infants with prenatally diagnosed congenital anomalies that contraindicate NIV, including congenital diaphragmatic hernia, choanal atresia, esophageal atresia with tracheoesophageal fistula, or congenital heart disease.
- Infants with multiple congenital anomalies.
- Infants requiring endotracheal intubation for positive pressure ventilation immediately after birth.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Arm 1 with arm label: Nasal Cannula
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Non-invasive ventilation delivered through a nasal cannula as the respiratory interface for one hour after randomization in preterm infants after birth.
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Aktiver Komparator: Arm 2 with arm label: Single Nasal Prong
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Non-invasive ventilation delivered through a single nasal prong as the respiratory interface for one hour after randomization in preterm infants after birth.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The need for endotracheal intubation
Zeitfenster: Within 1 hour after interface application.
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The proportion of preterm infants requiring endotracheal intubation during the first hour after application of the assigned non-invasive ventilation interface.
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Within 1 hour after interface application.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The need for Endotracheal Intubation
Zeitfenster: By 6 hours of age
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The proportion of preterm infants requiring endotracheal intubation by 6 hours of age.
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By 6 hours of age
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Oxygen Saturation Index (OSI)
Zeitfenster: At 1 hour after interface application
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Oxygen saturation index measured to assess respiratory effectiveness after 1 hour application of the assigned non-invasive ventilation interface.
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At 1 hour after interface application
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Partial Pressure of Carbon Dioxide (pCO₂)
Zeitfenster: At 1 hour after interface application
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Partial pressure of carbon dioxide (pCO₂) measured to evaluate ventilatory effectiveness at 1 hour after application of the assigned non-invasive ventilation interface.
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At 1 hour after interface application
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Blood pH
Zeitfenster: At 1 hour after interface application
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Blood pH measured to evaluate oxygenation effectiveness at 1 hour after application of the assigned non-invasive ventilation interface.
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At 1 hour after interface application
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Interface Dislodgement
Zeitfenster: Within 1 hour after interface application
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The proportion of infants experiencing dislodgement of the assigned non-invasive ventilation interface during the first hour after interface application.
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Within 1 hour after interface application
|
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Title Nasal Injury
Zeitfenster: At 1 hour after interface application
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Description The proportion of infants developing nasal injury associated with the assigned non-invasive ventilation interface during the first hour after interface application.
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At 1 hour after interface application
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 26-02-0251
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