CTRI

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CTRI Number

CTRI/2017/09/009910 [Registered on: 25/09/2017] Trial Registered Retrospectively

Last Modified On:

23/09/2017

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Process of Care Changes
Other (Specify) [Heated humidified high flow versus continuous positive airway pressure in preterm neonates ]

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

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

Scientific Title of Study

To study the Equivalence of High Flow Nasal Cannula Oxygen Therapy and Nasal Continuous Positive Airway Pressure as Respiratory support in Preterm neonates â€“ A Prospective Observational Study

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Laveena dias
Designation	Assistant Professor
Affiliation	Manipal University
Address	Women and Child Block First floor, NICU Kasturba Hospital Manipal, 576104 Udupi KARNATAKA 576104 India
Phone	8105344714
Fax	0000000
Email	laveenadias2002@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Leslie Edward Lewis
Designation	Professor of Paediatrics
Affiliation	Manipal University
Address	Women and Child Block First floor, NICU Kasturba Hospital Manipal, 576104 Women and Child Block First floor, NICU Kasturba Hospital Manipal, 576104 Udupi KARNATAKA 576104 India
Phone	9449208476
Fax	0000000
Email	leslielewis1@gmail.com

Details of Contact Person
Public Query

Name	Laveena dias
Designation	Assistant Professor
Affiliation	Manipal University
Address	Women and Child Block First floor, NICU Kasturba Hospital Manipal, 576104 Udupi KARNATAKA 576104 India
Phone	8105344714
Fax	0000000
Email	laveenadias2002@gmail.com

Source of Monetary or Material Support

Nil

Primary Sponsor

Name	Laveena Dias
Address	Women and Child Block First floor, NICU Kasturba Hospital Manipal, 576104
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Leslie Edward Lewis	Kasturba Hospital, Manipal University	Women and child block first floor, Department of Neonatlogy, Manipal Udupi KARNATAKA	9449208476 99999999 leslielewis1@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
InstitutionalEthicsCommittee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Preterm neonates,

Intervention / Comparator Agent

Type	Name	Details
Intervention	HHHFNC-Heated humidified high flow nasal cannula	Fischer & Paykel Optiflow junior with RT330 circuit consist of a gas inlet from an air-oxygen blender to the humidifier and then to the neonate through an inspiratory limb and the nasal cannulas were applied. The flow rates used were in the range of 1â€“8L/min, with a typical minimum flow rate of 2â€“4 L/min and maximum flow rate of 8 L/min . We recommended increasing the flow rate in 1 L/min increments if FIO2 increased by 10% above the starting FiO2, pCO2 increased by 10 mm Hg above the baseline value, increased distress or retractions were noted, or decreased lung expansion was noted on chest radiograph. We recommended decreasing the flow rate by 0.5- to 1.0- L/min increments if all of the following were sustained for at least a 4-hour period, if FiO2 30% and oxygen saturation within ordered parameters, pCO2 was maintained within ordered parameters, no signs of significant distress were noted, and lung expansion was adequate.
Comparator Agent	NCPAP-Nasal continuous positive airway pressure	The Drager Babylog 8000 plus was used for NCPAP. The interface named Drager Baby Flow Neo Nasal Masks of small, medium and large size with head cap was used. The recommended starting pressure for nCPAP was 4 to 5 cm H2O. nCPAP pressure could be increased to a maximum of 6 cm H2O on the basisof if, FIO2 increased by 10% above the starting FiO2,pCO2 increased by 10 mm Hg above the baseline value, increased distress or retractions were noted, or decreased lung expansion was noted on chest radiograph. nCPAP support was weaned by using if the FiO2 30% and oxygen saturation within ordered parameters, pCO2 was maintained within ordered parameters, no signs of significant distress were noted, and lung expansion was adequate.

Inclusion Criteria

Age From	1.00 Day(s)
Age To	2.00 Month(s)
Gender	Both
Details	all the preterm neonates less than 36weeks and downe score of more than 3.

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Case Record Numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
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

Outcome	TimePoints
Days on Non-invasive support(CPAP/HFNC) days on Ventilator Days on Oxygen supplementation Days on Non-invasive support(CPAP/HFNC) days on Ventilator Days on Oxygen supplementation Nasal mucosal Injury Pneumothorax Abdominal distension	100

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84"

Phase of Trial

N/A

Date of First Enrollment (India)

09/02/2015

Date of Study Completion (India)

01/06/2016

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="11"
Days="30"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

Nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

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.