A randomized trial of three non-invasive breathing support in preterm newborns

Comparative efficacy and safety of Non-Synchronized Non Invasive Positive Pressure Ventilation (NS-NIPPV) versus Synchronized Non Invasive Positive Pressure Ventilation (SNIPPV) versus Nasal High-Frequency Oscillatory Ventilation (NHFOV) as primary respiratory support in preterm neonates with respiratory distress: a randomized, open-label, three-arm trial - TRINIVENT

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110569

Enrollment

550

Registered

2026-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: P229- Respiratory distress of newborn, unspecified

Interventions

Intervention1: modes of non invasive respiratory support: Arm A NS NIPPV (non synchronized)with Initial settings PEEP 6 cm water PIP 15 to 20 cm water (peak inspiratory pressure delivered via nasal

Eligibility

Inclusion criteria

Inclusion criteria: 1. Inborn 2. Preterm neonates born at 26 to 33 completed weeks gestational age 3. Spontaneously breathing requiring non invasive respiratory support for respiratory distress within 6 hours of birth or after initial stabilization defined as one or more of persistent tachypnoea (RR more than 60) increased work of breathing oxygen requirement (Fractional inspired oxygen more or equal 0.25 to maintain Saturation target) or radiographic or clinical diagnosis of RDS. 4. Written informed parental or guardian consent

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies 2. Known or suspected chromosomal anomalies 3. Severe perinatal asphyxia ( Stage 3 HIE or APGAR less than 3 at 10 min with need for invasive ventilation). 4. Prior intubation and mechanical ventilation more than 1 hour before randomization 5. Decision for palliative care or anticipated limitation of life sustaining treatment 6. Outborn baby 7. Refused consent.

Design outcomes

Primary

Measure	Time frame
Need for invasive mechanical ventilation (endotracheal intubation)Timepoint: 72 Hours after randomization	—

Secondary

Measure	Time frame
1. Need for IMV within 7 days & before discharge. 2. BPD at 36 weeks PMA 3. Duration of non invasive respiratory support (hours per days). 4. Total respiratory support duration & ventilator free days to day 28. 5. Incidence of pneumothorax requiring drainage. 6. Time to first successful weaning from non invasive support. 7. Blood gas metrics (Partial pressure of carbon dioxide pH) Fractional inspired oxygen requirements at 6 12 24 48 & 72 hours. 8. Number of apnea bradycardia desaturation events recorded by bedside monitoring (predefined thresholds). 9. Adverse events & device related nasal trauma. 10. Intraventricular hemorrhage (IVH) grade 3 & above on cranial ultrasound 11. Incidence of necrotising enterocolitis ( Modified Bell Staging II & above) 12. Total duration of NICU stay 13. Total duration of hospitalisation 14. Death ( all causes) before dischargeTimepoint: 1. Need for IMV within 7 days & before discharge. 2. BPD at 36 weeks PMA 3. Duration of non invasive respiratory support. 4. Total respiratory support duration with ventilator free days to day 28. 5.Intraventricular hemorrhage grade 3 or above on cranial ultrasound before discharge 6. Incidence of necrotising enterocolitis(stage3 or stage4) before discharge 7. Death ( all causes) before discharge	—

Measure

Time frame

1. Need for IMV within 7 days & before discharge. 2. BPD at 36 weeks PMA 3. Duration of non invasive respiratory support (hours per days). 4. Total respiratory support duration & ventilator free days to day 28. 5. Incidence of pneumothorax requiring drainage. 6. Time to first successful weaning from non invasive support. 7. Blood gas metrics (Partial pressure of carbon dioxide pH) Fractional inspired oxygen requirements at 6 12 24 48 & 72 hours. 8. Number of apnea bradycardia desaturation events recorded by bedside monitoring (predefined thresholds). 9. Adverse events & device related nasal trauma. 10. Intraventricular hemorrhage (IVH) grade 3 & above on cranial ultrasound 11. Incidence of necrotising enterocolitis ( Modified Bell Staging II & above) 12. Total duration of NICU stay 13. Total duration of hospitalisation 14. Death ( all causes) before dischargeTimepoint: 1. Need for IMV within 7 days & before discharge. 2. BPD at 36 weeks PMA 3. Duration of non invasive respiratory support. 4. Total respiratory support duration with ventilator free days to day 28. 5.Intraventricular hemorrhage grade 3 or above on cranial ultrasound before discharge 6. Incidence of necrotising enterocolitis(stage3 or stage4) before discharge 7. Death ( all causes) before discharge

—

Countries

India

Contacts

Public ContactDr Madhurima Ganguly

IPGMER and SSKM Hospital

bijansaha18@gmail.com9051389120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026