High flow nasal cannulae versus nasal continuous posituve airway pressure in neonates with Respiratory distress syndrome.

Completed

• Conditions: Preterm neonates

• Registration Number: CTRI/2017/09/009910
• Lead Sponsor: Laveena Dias

Brief Summary

Non invasive ventilation (NIV) is the staple mode of ventilation in premature neonates and it has evolved and revolutionized over the last few decades so as to become one of the resuscitative maneuvers in Neonatal Resuscitation skill at the delivery room. Variety modalities have been introduced and found to be at par with each other given the situation. The concept of providing humidified heated flow (low or high) with or without positive end expiratory pressure (PEEP) through the nasal pathway has found miraculous result with the advantage of being noninvasive. The supplementation of oxygen is only indicated if the clinical features support like the saturation of oxygen in pulsatile arterial blood (SpO2) is not within the targeted ranges for the respective gestational ages. The need for newer modalities of noninvasive respiratory support in preterm neonates has always been a challenge and is still evolving with the aim of least injury or side effects to the neonate.

This study is focusing on 2 such noninvasive respiratory support methods in preterm neonates that are Nasal Continuous Positive Airway Pressure (NCPAP) and Heated Humidified High Flow Nasal Cannula (HHHFNC). Both have been used widely as a primary and weaning mode of non-invassive ventilation(NIV).

Result- A total 84 neonates were enrolled during the study period. There was no difference in early failure for HHHFNC (6/41) versus (7/43); p=0.34. NCPAP neonates remained on the study mode significantly longer than HHHFNC neonates in 33-36 weeks gestation strata(median:64 vs 43 hours, respectively;p<0.001).

HHHFNC did not decrease the need for invasive mechanical ventilation compared with NCPAP, in the first 72 hours of support but appears to have similar clinical efficacy and safety as a primary mode of non-invasive respiratory support.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-02
• Study Completion: 2016-01-06
• Last Update Posted: 2017-09-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

all the preterm neonates less than 36weeks and downe score of more than 3.

Exclusion Criteria

• 1.Neonates with congenital cyanotic heart disease.
• 2.Neonates with major congenital malformations.
• 3.Neonates with air leak syndromes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Failure of non invasive respiratory support requiring invasive ventilation support with 72 hours of initiation of therapy.	1.Requiring invasive ventilation support with 72 hours of initiation of therapy.

Secondary Outcome Measures

Name	Time	Method
Days on Non-invasive support(CPAP/HFNC) days on Ventilator	Days on Oxygen supplementation

Trial Locations

Locations (1)

Kasturba Hospital, Manipal University; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital, Manipal University

🇮🇳Udupi, KARNATAKA, India

Dr Leslie Edward Lewis

Principal investigator

9449208476

leslielewis1@gmail.com