To look for the use of high frequency oscillatory ventilation for reducing the rates of intubation

Noninvasive high frequency oscillatory ventilation versus Noninvasive intermittent positive pressure ventilation as a primary respiratory support in preterms with respiratory distress syndrome- A Randomized Control Trial - N I F H T

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066150

Enrollment

150

Registered

2024-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Control Intervention1: Noninvasive intermittent positive pressure ventilation: will be initiated in pretrems at initial settings of - PIP -12-14 /FIO2-30%, Rate -40/minute Control Intervention2: NO

Eligibility

Inclusion criteria

Inclusion criteria: Gestational age (GA) is between 26 and less than 34 weeks. GA will be determined by dates or a dating ultrasound. If not available- New Ballards score will be used to determine gestational age Diagnosis of RDS -The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring, and or grunting) within the first 1 hour of life. Chest Xray will be done within 1 hour of life . Informed parental consent

Exclusion criteria

Exclusion criteria: 1.Any baby intubated for resuscitation or for other reasons. 2. Major congenital malformations or known complex congenital heart disease. 3. Refusal to consent

Design outcomes

Primary

Measure	Time frame
Need for Invasive Mechanical ventilation in the first 72 hours of life in preterm randomized to the three groupsTimepoint: first 72 hours of life	—

Secondary

Measure	Time frame
1. Days of hospitalization, 2. Days on NIV, 3. Days on supplemental oxygen, 4. Pre-discharge mortality, 5. Surfactant doses, 6. Retinopathy of prematurity, 7. Bronchopulmonary dysplasia , 8. Abdominal distention, feed intolerance, time to full feed, air leaks 9. Intraventricular hemorrhage , 10. Spontaneous intestinal perforation, 11. Presence of thick secretions causing an airway obstruction Timepoint: Death Discharge	—

Measure

Time frame

1. Days of hospitalization, 2. Days on NIV, 3. Days on supplemental oxygen, 4. Pre-discharge mortality, 5. Surfactant doses, 6. Retinopathy of prematurity, 7. Bronchopulmonary dysplasia , 8. Abdominal distention, feed intolerance, time to full feed, air leaks 9. Intraventricular hemorrhage , 10. Spontaneous intestinal perforation, 11. Presence of thick secretions causing an airway obstruction Timepoint: Death Discharge

—

Countries

India

Contacts

Public ContactDr Laxmikant Deshmukh

Government Medical college , Sambhaji Nagar

deshmukhls@yahoo.com9822478275

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026