| CTRI Number |
CTRI/2024/01/062020 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
can supporting babys breaths without tube after removing the endotracheal tube reduce the need of re insertion of the endotracheal tube |
|
Scientific Title of Study
|
role of non-invasive ventilation in reducing extubation failure in term neonates |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchi Rai |
| Designation |
Professor, Neonatology |
| Affiliation |
Postgraduate Institute of Child Health, Sector 30, Noida |
| Address |
Department of Neonatology, Postgraduate Institute of Child Health, Sector 30, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
08874628287 |
| Fax |
|
| Email |
ruchiraialld@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ruchi Rai |
| Designation |
Professor, Neonatology |
| Affiliation |
Postgraduate Institute of Child Health, Sector 30, Noida |
| Address |
Department of Neonatology, Postgraduate Institute of Child Health, Sector 30, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
08874628287 |
| Fax |
|
| Email |
ruchiraialld@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruchi Rai |
| Designation |
Professor, Neonatology |
| Affiliation |
Postgraduate Institute of Child Health, Sector 30, Noida |
| Address |
Department of Neonatology, Postgraduate Institute of Child Health, Sector 30, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
08874628287 |
| Fax |
|
| Email |
ruchiraialld@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Child Health, Noida UP |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [no sponsors] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi Rai |
postgraduate Institute of Child Health |
Neonatal Intensive Care Unit, Department of Neonatology, 1st Floor
Gautam Buddha Nagar
UTTAR PRADESH |
08874628287
ruchiraialld@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC Super Speciality Pediatric Hospital and Postgraduate Teaching Institute |
Approved |
| IEC, Super Specilaity Pediatric Hospital and postgraduate Teaching Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P039||Newborn affected by complication of labor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
continuous positive airway pressure |
Term neonates on mechanical ventilation will receive nasal continuous positive pressure ventilation (CPAP) through a bubble CPAP machine immediately after extubation |
| Comparator Agent |
heated humidified high flow nasal cannula and low flow oxygen |
baby will be given high flow oxygen through heated humidified high nasal cannula or low oxygen through a nasal cannula |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
all term babies (gestational age ≥ 37 weeks) on mechanical ventilation when ready for extubation will be included in the study. |
|
| ExclusionCriteria |
| Details |
i) major congenital malformation ii) genetic syndromes iii) babies who underwent gastrointestinal surgery iv) airway malformations |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of nasal CPAP (CPAP), heated humidified high flow nasal cannula (HFNC) and low flow oxygen (LFO) in reducing extubation failure within 72 hours of extubation in term babies. |
To compare the efficacy of nasal CPAP (CPAP), heated humidified high flow nasal cannula (HFNC) and low flow oxygen (LFO) in reducing extubation failure within 72 hours of extubation in term babies. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i) to study the profile of term neonates on mechanical ventilation
ii) To study the other secondary outcomes i) need for reintubation, ii) duration of oxygen need, iii) duration of hospital stay & iv) mortality in the three groups
|
24,48,72 hours of extubation |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Proposal
summary
Aim: To study the role of non-invasive ventilation in reducing
extubation failures in term neonates
Primary
objective: To compare the efficacy of nasal CPAP
(CPAP), heated humidified high flow nasal cannula (HFNC) and low flow oxygen
(LFO) in reducing extubation failure within 72 hours of extubation in term babies.
Secondary
objective: i) to study the profile of term neonates
on mechanical ventilation
ii) To study the
other secondary outcomes i) need for reintubation, ii) duration of oxygen need,
iii) duration of hospital stay and iv) mortality in the three groups
Inclusion
criteria: all term babies (gestational age ≥ 37 weeks) on mechanical ventilation when ready for extubation will
be included in the study.
Exclusion
criteria: i) major congenital malformation ii)
genetic syndromes iii) babies who underwent gastrointestinal surgery iv) airway
malformations
Term neonates on
mechanical ventilation will be randomised when they are ready to be extubated, to
receive nasal continuous positive pressure ventilation (CPAP) or heated
humidified high flow nasal oxygen (HFNC) or low flow oxygen (LFO) (≤ 1 Lit/m) by prongs immediately after extubation. All babies who
were ventilated for ≥ 7 days will be given intravenous
dexamethasone in a dose of 0.15 mg/kg/day for 3 doses 8 hours apart starting 2
hours prior to planned extubation. All standard treatment protocols will be
followed. Randomization will be done by
a computer software into three groups. The allocated group will be placed in a
sequentially numbered opaque sealed envelope and will be opened at the time of
enrolment.
Extubation failure will be defined as any
one of the following in a neonate on maximum support in each group; i) > 3
episodes of apnea (duration ≥ 20 sec) over a period of 1 hour or any episode of
apnea needing positive pressure ventilation ii) Silverman Anderson score > 5
iii) neonate not able to maintain saturation 90-95%. Maximum support will be
defined as CPAP pressure of 7 cm H2O in CPAP group or flow rate of
7L/min in HFNC group and on flow rate of 1L/min in the LFO group
All babies having extubation failure
on HFNC and LFO group will be started on nasal CPAP as a rescue therapy. CPAP
failure in these babies will be defined as mentioned earlier. Babies having
extubation failure on CPAP will be intubated and stared on mechanical
ventilation.
Sample size: Based on the previous
studies a sample size of 35 babies will be taken for each group.
All data will be analysed using Epi info
7. |