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Comparison of two modes of ventilation NHFOV( newer entity) and NIPPV( pre existing entity) in premature babies who require respiratory support.

Non-invasive High Frequency Oscillation Ventilation versus Non-invasive intermittent positive pressure ventilation as primary mode of ventilation in preterm neonates requiring respiratory support.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/053140
Enrollment
140
Registered
2023-05-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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: Non-invasive High Frequency Oscillation Ventilation NHFOV: In NHFOV, there is application of bias flow which generates a continuous distending positive pressure with oscillations superi

Sponsors

Pt.B D Sharma University Health Sciences,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All inborn preterm neonates from 28 to 34+6 weeks of life requiring respiratory support with Silverman Anderson Score > 3.

Exclusion criteria

Exclusion criteria: ï?· Neonates who are outborn. ï?· Neonates who need intubation for surfactant administration. ï?· Neonates with significant morbidity apart from RDS including cardiac disease, congenital malformations, upper airway anomalies, suspected metabolic disorders, severe cardiovascular instability. ï?· Neonates who had either respiratory distress secondary to severe asphyxia (Apgar score <= 3 at 1 and 5 minute), severe intraventricular hemorrhage (IVH) on admission. ï?· Neonates whose parents refuse consent.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the need for invasive mechanical ventilation within the first 72 hours of life and total duration of respiratory support through NHFOV or NIPPV.Timepoint: At 72 hours of life

Secondary

MeasureTime frame
The secondary outcomes will be duration of respiratory support duration of hospitalization, time taken to reach full spoon feeds,incidence of air leaks, grade 3 and 4 IVH, BPD, traumatization of nasal skin and mucosa, rate of feed intolerance.Timepoint: -at the time of Weaning off the respiratory support -at the time of discharge -at the time of attainment of full spoon feeds. -babies will be under continuous monitoring in nicu,events will be registered as soon as they happen.

Countries

India

Contacts

Public ContactJitanshu

PGIMS , ROHTAK

geetagathwala@gmail.com9896489650

Outcome results

None listed

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