| CTRI Number |
CTRI/2024/07/069733 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study to compare two ways of helping premature babies stop using Non -invasive breathing support .
ONE METHOD will be gradual reduce the support while the other method would be to stop the support suddenly . |
|
Scientific Title of Study
|
Sudden versus Gradual Weaning from NIV support in preterm neonates :- A Randomized Controlled Trial . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varsha Jain |
| Designation |
Post graduate student in Department of Pediatrics of University College of Medical Sciences |
| Affiliation |
University college of medical sciences and Guru tegh bahadur Hospital ,Delhi |
| Address |
Department of Pediatrics , University college of medical sciences and Guru Tegh Bahadur Hospital , Dilshad garden , Delhi -110095
North East
DELHI
110095
India |
| Phone |
8076554539 |
| Fax |
|
| Email |
varshajain288@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUSHIL SRIVASTAVA |
| Designation |
Professor , Department of Pediatrics |
| Affiliation |
University college of medical sciences and Guru tegh bahadur Hospital , Delhi |
| Address |
Department of Pediatrics , University college of medical sciences and Guru tegh bahadur Hospital , Dilshad garden , Delhi -110095
North East
DELHI
110095
India |
| Phone |
9718502133 |
| Fax |
|
| Email |
vastava0309@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Jain |
| Designation |
Post graduate student in Department of Pediatrics of University College of Medical Sciences |
| Affiliation |
University college of medical sciences and Guru tegh bahadur Hospital ,Delhi |
| Address |
Department of Pediatrics , University college of medical sciences and Guru tegh bahadur Hospital , Dilshad garden , Delhi -110095
North East
DELHI
110095
India |
| Phone |
8076554539 |
| Fax |
|
| Email |
varshajain288@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru tegh bahadur Hospital, Department of pediatrics , dilshad garden -110095
INDIA |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences AND GTB HOSPITAL |
| Address |
DILSHAD GARDEN , DELHI -110095 |
| Type of Sponsor |
Government medical college |
|
|
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 Varsha Jain |
University college of medical sciences and Guru tegh bahadur Hospital, Delhi |
ROOM NO - P-603,
MCH 6th floor .
Department of pediatrics.
Division neonatology,
Dilshad Garden , Delhi - 110095, INDIA
North East
DELHI |
8076554539
varshajain288@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE- HUMAN RESEARCH (IEC-HR), UNIVERSITY OF MEDICAL SCIENCES ,UNIVERSITY OF DELHI , DELHI -110095,CDSCO Registration no. ECR/1924/Inst/DL/2024,DHR Registration No. EC/NEW/INST/2021/2098 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GRADUAL WEANING of NIV Support in preterm neonate of gestation 28 to 36 week. |
In gradual weaning protocol GROUP B we will wean of the NIV support over a period of 8hr by using first oxygen weaning (reduction of fio2 by 5% every 2hr ) ensuring maintaining saturation90 to 95 %.followed by pressure weaning (that is reduction of PEEP by 1cmh2o every 2hr ) till PEEP OF 5CM h2o |
| Intervention |
SUDDEN WEANING of NIV Support in preterm neonate of gestation 28 to 36 week . |
In sudden weaning protocol ( GROUP A) we will wean of the NIV Support within 2hrs by using first oxygen weaning ( reduction of Fio2 by 5% every 30 min) ensuring saturation 90 to 95% .followed by pressure weaning (that is reduction of PEEP by 1cmh2o every 30 min ) till PEEP of 5cmh2o |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All preterm neonates (28 to 36 week) on NIV Support and met the weaning readiness criteria .
1. Clinically stable neonate on NIV,PEEP of less than equal to 6cm H2O,Fio2 less than equal to 0.35percent, Maintaining Spo2 90-95percent for a minimum of 12 hours.
2. Normal work of breathing:no persistent tachypnea (more than 60 breaths for more than 2hr ),no marked retractions .
3. Hemodynamically stable .
4.NO APNEA associated with bradycardia or cyanosis with more than 2 episode in 12hr or more than 3 in 24hr with at least one requiring bag and mask ventilation .
5.Not currently treated for Patent ductus arteriosus.
6.Tolerated time off NIV during nursing cluster care for up to 5 to 10 minutes.
7. Pip of less than equal to 15 cm H20 and backup respiratory rate of less than equal to 50 percent of total respiratory rate.
2. |
|
| ExclusionCriteria |
| Details |
Preterm neonates with chromosomal defects and severe congenital anomalies including congenital heart disease , neurological malformations , chest wall or airway abnormalities and lung hypoplasia . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of preterm neonates successfully weaned in the first attempt of weaning in each group. |
Randomization to off oxygen for 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean post -menstrual age at the time of successful wean in both the group.
2. Mean weight at time of successful wean in both the group.
3.Total duration of NIV Support in successfully weaned preterm neonates of each group .
4.Length of stay (LOS) in NICU in successfully weaned preterm neonates of each group . |
1.Randomization to off oxygen for 3 days .
2.Randomization to off oxygen for 3 days.
3.Date from patient require NIV to Off NIV support.
4 Date of admission to Date of discharge/death/lama/abscond/refered to another hospital. |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
SUMMARY OF PROTOCOL Title: sudden versus gradual weaning from NIV Support in preterm neonates: - A Randomized controlled trial. RATIONALE: The present study aims to test novel weaning strategies in preterm neonates on NIV support. Primary Objective: To compare the success rate of the first attempt of successful weaning in the sudden versus gradual wean group in preterm neonates (28 to 36wk). Secondary Objectives: To compare the following factors in the sudden versus gradual wean group: - Postmenstrual age (PMA) at the time of successful weaning and weight at the time of successful weaning. Total duration of NIV support and Length of stay (LOS) in NICU Study Setting: Neonatal ICU (intramural) of the Department of Pediatrics of GTB Hospital, a tertiary care teaching hospital in New Delhi. Study Period: April 2024 to Aug 2025 Study Design: A Randomized Controlled Trial. Participants: 160 Preterm neonates (28 to 36 weeks) admitted in intramural NICU requiring NIV support. Methods: Eligible preterm neonates in the intramural NICU of GTBH will be enrolled in the study after obtaining informed consent from parents and counselling them. Clinic-demographic data will be noted in a pre-designed case record form (CRF). The Baby enrolled in the study undergoes randomization into the sudden versus gradual wean group and the baby is asses in each group for successful weaning. Successful weaning in each group is defined as being off oxygen for 3 days. Primary Outcome Measures: Proportion of preterm neonates successfully weaned in the first attempt of weaning in each group. Secondary Outcome: Mean postmenstrual age at the time of successful wean in both the group , Mean weight at the time of successful wean in both the group , Total duration of NIV support in successful weaned preterm neonates of each group, Length of stay (LOS) in NICU in successful weaned preterm neonates of each group. Sample size: Considering the success rate of weaning in sudden is 40% (Amatya et al ) (18) and 62.8% (Amatya et al ) (18) in the gradual group. To estimate this difference in success rate at alpha error 0.05 and power = 80%, a sample of size 72 subjects is required in each group (we will take 80 subject in each group ) , which is a total of 160. Statistical Analysis: For the primary outcome , the significance of differences in proportion successfully weaned between the groups will be tested by Chi–square Test (Fischer exact Test if applicable ) .For the secondary outcome (Mean post menstrual age , Mean weight , Total duration of NIV support , Mean length of stay in NICU ) will be compared by applying Unpaired –T-Test (Mann–Whitney Test if applicable ). P < 0.05 will be taken as significant.
|