Efficacy of high flow nasal cannula vs standard Oxygen delivery for management of Transient Tachypnea of New born- A Randomized control trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1.To compare the duration of oxygen requirement between HFNC and standard oxygen therapy.
Overview
Brief Summary
· Currently most of the babies with mild to moderate respiratory distress managed with oxygen therapy via nasal cannula. Previous studies demonstrated that just five minutes of respiration using ambient gas with no heating or humidification in ventilated infants resulted in a significant decrease in both pulmonary compliance and conductance. Cool, dry air induces a bronchoconstriction response, increases resistance of airway.High-flow nasal cannula systems are designed with proper gas conditioning such as inline warming and humidification systems of supplied gas. Over last 2 decades there is increasing acceptance of HFNC among neonatal health care provider for management of respiratory distress in neonates.For this study, all cases satisfying inclusion criteria admitted in KIMS, Bhubaneshwar from time period of march 2023-Feb2025 will be considered. Written consent from parents will be obtained after explaining them regarding intervention done. Baseline demographic maternal and neonatal characteristics will be noted.Subjects will be assigned into two arms of study by simple randomisation as per inclusion and exclusion criteria.Newborns randomized to HFNC will be started on a flow rate of 4L/min and FiO2 adjusted to maintain oxygen saturations between 91-95%. Once initiated, the measures will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 8L/min and FiO2 of 60%. The nasal cannula size (0.2 cm or 0.3 cm outer diameter) will determined by the caliber of the subject’s nares).The NC flow will be started either at 0.5-1lit/min (acc. To WHO guidelines). The maximum flow to be titrated upto 4 l/min to attain target saturations 91–95% according to our institutional protocol. The size of nasal cannula will be determined by the caliber of the subject’s nares.Study participants who fail to respond to the assigned respiratory modality to be upgraded to either CPAP or mechanical ventilation based on the severity of RD and neonatologist’s decision.Study subjects follwed up for time required on oxygen support.Statistical Analysis done using collected data.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 1.00 Day(s) to 2.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •gestational age ≥ 34 weeks admitted within first 6 hours of life.
Exclusion Criteria
- •Congenital anomalies incompatible with life.
- •history of thick meconium stained fluid and/or diagnosis of meconium aspiration syndrome 3)antenatal diagnosis of major congenital pulmonary or cardiac anomalies 4)initial CXR/ clinical finding demonstrating air leak 5)Downe score ≥ 6 6)Severe Respiratory distress syndrome.
Outcomes
Primary Outcomes
1.To compare the duration of oxygen requirement between HFNC and standard oxygen therapy.
Time Frame: Respiratory distress score at 6, 12 and 24 hours of starting HFNC or standard oxygen therapy.
Secondary Outcomes
- 1.Comparison of Respiratory distress score (Downe’s score) at 6, 12 and 24 hrs of life.(2.To compare need of advanced respiratory support (CPAP/Mechanical ventilation) in both arms.)