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Clinical Trial Details (PDF Generation Date :- Tue, 08 Mar 2022 04:21:45 GMT)

CTRI Number CTRI/2019/10/021633 [Registered on: 14/10/2019] - Trial Registered Prospectively

Last Modified On 12/06/2021
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Process of Care Changes
Study Design Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Breathing stabilization in small babies at the time of birth
Scientific Title of Delivery room respiratory stabilization of preterm neonates: A randomized controlled trial
Study
Secondary IDs if Any Secondary ID Identifier
AIIMS/IEC/19/1040/version 1/dated 27.09.2019 Protocol Number
Details of Principal Details of Principal Investigator
Investigator or overall
Name Sriparna Basu
Trial Coordinator
(multi-center study) Designation Professor & Head, Department of Neonatology
Affiliation All India Institute of Medical Sciences, Rishikesh
Address Room No. 16123 Block A, Medical College Building Department of
Neonatology All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India
Phone 9935340260
Fax
Email [email protected]
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Rajat Grover
Query)
Designation Academic Senior Resident (DM Neonatology)
Affiliation All India Institute of Medical Sciences, Rishikesh
Address Room No. 13112 Neonatal Intensive Care Unit B-Block, Hospital
building All India Institute of Medical Sciences Rishikesh
Dehradun
UTTARANCHAL
249203
India
Phone 8447147054
Fax
Email [email protected]
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Sriparna Basu
Designation Professor & Head, Department of Neonatology
Affiliation All India Institute of Medical Sciences, Rishikesh
Address Room No. 16123 Department of Neonatology Block A, Medical
College Building All India Institute of Medical Sciences Rishikesh
Dehradun
UTTARANCHAL
249203
India
Phone 9935340260

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Fax
Email [email protected]
Source of Monetary or Source of Monetary or Material Support
Material Support
> All India Institutute of Medical Sciences, Rishikesh, India
Primary Sponsor Primary Sponsor Details
Name All India Institutute of Medical Sciences Rishikesh
Address All India Institutute of Medical Sciences, Rishikesh, Uttaranchal -
249203, India
Type of Sponsor Government medical college
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr Sriparna Basu All India Institute of Labor Room Complex 0993534026
Medical Sciences, and Obstetric Operation
Rishikesh Theater Level 3, B sriparna.neonat@aiimsr
Block, Hospital ishikesh.edu.in
Building, Department of
Gyne and Obstetrics
and Labor Room
Nursery and Neonatal
Intensive Care Unit
Level 3, B Block,
Hospital Building,
Department of
Neonatology Dehradun
UTTARANCHAL
Dehradun
UTTARANCHAL
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Institutional Ethics Approved 27/09/2019 No
Committee, All India
Institute of Medical
Sciences, Rishikesh
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients Newborn affected by complication of labor and
delivery, unspecified
Intervention / Type Name Details
Comparator Agent
Intervention Humidified high flow nasal Humidified high flow nasal
cannula (Optiflow Junior, Fisher cannula will be started at an
& Paykel Healthcare) initial flow-rate of 4-6 L/min and
FiO2 to maintain minute-specific
SpO2 according to the
nomogram of American
Academy of Pediatrics for initial
10 minutes and 90-94%
subsequently

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Comparator Agent Nasal continuous positive Bubble CPAP will be started at

airway pressure (CPAP) (bubble an initial CPAP pressure of 5
CPAP, Fisher & Paykel cm of water with sequential
Healthcare) increase by 1 cm of water
whenever indicated up to a
maximum pressure of 8 cm of
water. FiO2 would be increased
in increments of 0.1 as per
requirement.
Inclusion Criteria Inclusion Criteria
Age From 0.00 Day(s)
Age To 1.00 Day(s)
Gender Both
Details 1. Spontaneously breathing inborn neonates <br/> of gestational age
between 28+0 weeks to 36+6 <br/> weeks having a birth weight ?
800 g.<br/> 2. Presence of any one sign of respiratory <br/> distress,
such as,<br/> i. tachypnea (respiratory rate >60/min) <br/> ii.
subcostal and/or intercostal retractions <br/> iii. grunting<br/> iv.
nasal flaring<br/> 2. FiO2 requirement more than 0.3 to maintain
<br/> minute specific target oxygen saturations as <br/> advised by
the neonatal resuscitation <br/> guidelines of the American Academy
of <br/> Pediatrics.<br/>
Exclusion Criteria Exclusion Criteria
Details 1. Requirement of intubation at birth as per
neonatal resuscitation guidelines of the
American Academy of Pediatrics guidelines
2. Major congenital anomalies
3. Inability to attain parental consent

Method of Generating Stratified block randomization

Random Sequence
Method of Sequentially numbered, sealed, opaque envelopes
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome Timepoints
Treatment failure defined as FiO2 requirement of 24 hours after randomization
0.4 or greater, arterial blood gas pH 7.2 or less
with PaCO2 more than 50 mm Hg, multiple
episodes of apnea requiring positive pressure
ventilation and need for urgent intubation and
mechanical ventilation despite providing maximal
available support
Secondary Outcome Outcome Timepoints
1.Time to treatment failure At discharge from hospital and till 1 year at
2.Need for surfactant different time points
3.Duration of respiratory support and
supplemental oxygen
4.Age of starting feeds and time to achieve full
feeds
5.Duration of hospital stay
6.Weight at discharge
7.Adverse events including death,nasal trauma,
air leak syndrome, shock, patent ductus
arteriosus, sepsis, necrotising enterocolitis,
intestinal perforation, bronchopulmonary
dysplasia, retinopathy of prematurity,

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intraventricular hemorrhage, periventricular

leukomalacia

Target Sample Size Total Sample Size=124

Sample Size from India=124
Final Enrollment numbers achieved (Total)=124
Final Enrollment numbers achieved (India)=124
Phase of Trial N/A
Date of First 23/10/2019
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=2
Trial Months=6
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details Nil
Brief Summary

Importance: Heated, humidified high flow nasal cannula (HHHFNC) is

gaining favor as an alternative to nasal continuous positive airway

pressure (NCPAP) to provide respiratory support in preterm neonates.

However, there is a paucity of evidence regarding the use of HHHFNC for

delivery room (DR) respiratory stabilization.

Objective: To determine whether HHHFNC is non-inferior to NCPAP for

provision of DR respiratory support to preterm neonates of gestational age

(GA) >28 weeks.

Design, setting, and participants: This randomized controlled

non-inferiority trial was conducted at a tertiary level neonatal intensive care

unit from October 2019 to January 2021. Spontaneously breathing inborn

neonates between 28 to 36 weeks gestation were enrolled if they had any

sign of respiratory distress soon after birth and/or needed FiO2 >0.3 to

maintain minute-specific target oxygen saturations in DR.

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Interventions: A total of 124 neonates were randomized to receive either

HHHFNC (n=61) at 4-8 L/min or NCPAP (n=63) at 5-8 cm H2O in the

delivery room. Randomization was stratified as per gestation.

Main Outcomes and Measures: Primary outcome measure was

treatment failure within 24 hours. The absolute risk difference in the

treatment failure rate and it’s 95% confidence interval (CI) were calculated

with a non-inferiority margin of 10%. Secondary outcome variables were

temperature at admission, time to treatment failure, treatment failure at 72

hours, need for surfactant, intubation, duration of respiratory support, age

of initiation and time to achieve full feeds, hospital stay, weight at

discharge, and incidence of adverse events including mortality.

Results: Both the groups were similar in baseline characteristics. There

was no statistically significant difference between the treatment failure

rates with HHHFNC (13.1%) and NCPAP (11.1%) (Risk difference 2.0%,

95% CI -9.9% to 14.07%, p=0.73). However, non-inferiority of HHHFNC to

NCPAP could not be conclusively proved as the 95% CI crossed both 0

and the noninferiority margin 10%. There were no significant differences in

secondary outcomes.

Conclusions and relevance: HHHFNC showed similar efficacy and

safety as NCPAP for DR respiratory stabilization of preterm neonates.

Given its ease of application and patient comfort HHHFNC may be a

suitable option for respiratory stabilization in delivery room.

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