A study comparing two modes of oxygen delivery systems (nasal high frequency oscillation ventilation and nasal continuous positive airway pressure) in premature babies who have immature lung.

Nasal high frequency oscillation ventilation versus Nasal continuous positive airway pressure as primary respiratory support in preterm neonates of more than 30weeks gestation with Respiratory distress syndrome: an Open labelled Randomized controlled trial - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074939

Enrollment

124

Registered

2024-10-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

None listed

Interventions

Intervention1: nasal HFOV in a preterm neonate more than 30 weeks gestation with respiratory distress syndrome: Nasal High Frequency oscillation ventilation will be initiated in a baby diagnosed with

Eligibility

Inclusion criteria

Inclusion criteria: preterm neonates of gestational age 30-36+6/7 weeks diagnosed with respiratory distress syndrome

Exclusion criteria

Exclusion criteria: neonates who had undergone endotracheal intubation or had received surfactant prior to randomization , neonates with gross congenital anomalies whose caretakers refuse to give consent to participate in study

Design outcomes

Primary

Measure	Time frame
Treatment failure Defined as requirement of an use of an alternative NRS modality NIPPV or BiPAP, Requirement of IMV within 72 hours of postnatal age Timepoint: Treatment failure Defined as requirement of an use of an alternative NRS modality NIPPV or BiPAP, Requirement of IMV within 72 hours of postnatal age	—

Secondary

Measure	Time frame
Requirement of surfactant replacement therapy, Pneumothorax, Mortality or BPD (defined as oxygen requirement at 28 days of postnatal age), Mortality, BPD (defined as oxygen requirement at 28 days of postnatal age), Duration of NRS support, Duration of IMV support, Duration of both NRS and IMV support, Duration of hospital stay, Severe intraventricular hemorrhage, Necrotizing enterocolitis stage 2 or more as per modified Bell’s staging, Retinopathy of prematurity (ROP) requiring intervention, Nasal injuryTimepoint: respiratory support started within 6hours	—

Measure

Time frame

Requirement of surfactant replacement therapy, Pneumothorax, Mortality or BPD (defined as oxygen requirement at 28 days of postnatal age), Mortality, BPD (defined as oxygen requirement at 28 days of postnatal age), Duration of NRS support, Duration of IMV support, Duration of both NRS and IMV support, Duration of hospital stay, Severe intraventricular hemorrhage, Necrotizing enterocolitis stage 2 or more as per modified Bell’s staging, Retinopathy of prematurity (ROP) requiring intervention, Nasal injuryTimepoint: respiratory support started within 6hours

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Countries

India

Contacts

Public ContactPadamata Likhitha

Ankura hospital for women and children

likhithaverma2904@gmail.com9676303665

Outcome results