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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Raden Adhi Teguh Perma Iskandar, Principal Investigator
- Telefoonnummer: 085779153162
- E-mail: adhitpi@gmail.com
Studie Contact Back-up
- Naam: Ina Rochayati
- Telefoonnummer: 087712526805
- E-mail: inarochayati@gmail.com
Studie Locaties
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonesië
- Rumah Sakit dr. Cipto Mangunkusumo
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Contact:
- Raden Adhi Teguh Perma Iskandar, Principal Investigator
- Telefoonnummer: 085779153162
- E-mail: adhitpi@gmail.com
-
Contact:
- Rochayati Ina
- Telefoonnummer: 087712526805
- E-mail: inarochayati@gmail.com
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
|
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Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The need for endotracheal intubation
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The need for Endotracheal Intubation
Tijdsspanne: By 6 hours of age
|
The proportion of preterm infants requiring endotracheal intubation by 6 hours of age.
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By 6 hours of age
|
|
Oxygen Saturation Index (OSI)
Tijdsspanne: 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.
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At 1 hour after interface application
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Partial Pressure of Carbon Dioxide (pCO₂)
Tijdsspanne: 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
|
|
Blood pH
Tijdsspanne: 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
|
|
Interface Dislodgement
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 26-02-0251
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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