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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Raden Adhi Teguh Perma Iskandar, Principal Investigator
- Telefonnummer: 085779153162
- E-mail: adhitpi@gmail.com
Undersøgelse Kontakt Backup
- Navn: Ina Rochayati
- Telefonnummer: 087712526805
- E-mail: inarochayati@gmail.com
Studiesteder
-
-
DKI Jakarta
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Jakarta, DKI Jakarta, Indonesien
- Rumah Sakit dr. Cipto Mangunkusumo
-
Kontakt:
- Raden Adhi Teguh Perma Iskandar, Principal Investigator
- Telefonnummer: 085779153162
- E-mail: adhitpi@gmail.com
-
Kontakt:
- Rochayati Ina
- Telefonnummer: 087712526805
- E-mail: inarochayati@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1 with arm label: Nasal Cannula
|
Non-invasive ventilation delivered through a nasal cannula as the respiratory interface for one hour after randomization in preterm infants after birth.
|
|
Aktiv komparator: Arm 2 with arm label: Single Nasal Prong
|
Non-invasive ventilation delivered through a single nasal prong as the respiratory interface for one hour after randomization in preterm infants after birth.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The need for endotracheal intubation
Tidsramme: Within 1 hour after interface application.
|
The proportion of preterm infants requiring endotracheal intubation during the first hour after application of the assigned non-invasive ventilation interface.
|
Within 1 hour after interface application.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The need for Endotracheal Intubation
Tidsramme: By 6 hours of age
|
The proportion of preterm infants requiring endotracheal intubation by 6 hours of age.
|
By 6 hours of age
|
|
Oxygen Saturation Index (OSI)
Tidsramme: At 1 hour after interface application
|
Oxygen saturation index measured to assess respiratory effectiveness after 1 hour application of the assigned non-invasive ventilation interface.
|
At 1 hour after interface application
|
|
Partial Pressure of Carbon Dioxide (pCO₂)
Tidsramme: At 1 hour after interface application
|
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
|
|
Blood pH
Tidsramme: At 1 hour after interface application
|
Blood pH measured to evaluate oxygenation effectiveness at 1 hour after application of the assigned non-invasive ventilation interface.
|
At 1 hour after interface application
|
|
Interface Dislodgement
Tidsramme: Within 1 hour after interface application
|
The proportion of infants experiencing dislodgement of the assigned non-invasive ventilation interface during the first hour after interface application.
|
Within 1 hour after interface application
|
|
Title Nasal Injury
Tidsramme: At 1 hour after interface application
|
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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-02-0251
Plan for individuelle deltagerdata (IPD)
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