Prematurity
Conditions
Brief summary
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.
Interventions
DEVICEExperimental, Intervention Name: Nasal Cannula
Non-invasive ventilation delivered through a nasal cannula as the respiratory interface for one hour after randomization in preterm infants after birth.
DEVICEActive comparator: 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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: 1. Preterm infants with a gestational age of 28 to \<37 weeks who develop respiratory distress and require non-invasive ventilation (NIV) after birth. 2. Written informed consent is obtained from a parent or legal guardian.
Exclusion criteria
1. Infants with congenital nasal defects, including cleft lip and palate. 2. Infants with prenatally diagnosed congenital anomalies that contraindicate NIV, including congenital diaphragmatic hernia, choanal atresia, esophageal atresia with tracheoesophageal fistula, or congenital heart disease. 3. Infants with multiple congenital anomalies. 4. Infants requiring endotracheal intubation for positive pressure ventilation immediately after birth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The need for endotracheal intubation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The need for Endotracheal Intubation | By 6 hours of age | The proportion of preterm infants requiring endotracheal intubation by 6 hours of age. |
| Oxygen Saturation Index (OSI) | 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. |
| Partial Pressure of Carbon Dioxide (pCO₂) | 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. |
| Blood pH | 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. |
| Interface Dislodgement | 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. |
| Title Nasal Injury | 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. |
Countries
Indonesia
Contacts
CONTACTRaden Adhi Teguh Perma Iskandar, Principal Investigator
CONTACTIna Rochayati
Outcome results
None listed