| CTRI Number |
CTRI/2026/03/106730 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of change of position of newborn on total duration of ventilator days in preterm newborns (less than 34 weeks of gestation) |
|
Scientific Title of Study
|
Impact of cyclical positioning on total duration of ventilation in pretrem neonates (less than 34 weeks) -a randomised 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 |
Emilee Das |
| Designation |
DM Resident Neonatology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Neonatology Inborn and outborn units,Maulana Azad Medical College and Lok Nayak Janpratinidhi Hospital
Central
DELHI
110002
India |
| Phone |
9870568316 |
| Fax |
|
| Email |
dasemilee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashish Jain |
| Designation |
Professor, Head of Department , Neonatology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Neonatology, Maulana Azad Medical College and Lok Nayak Janpratinidhi Hospital
Central
DELHI
110002
India |
| Phone |
9810694789 |
| Fax |
|
| Email |
neoashish2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Emilee Das |
| Designation |
DM Resident Neonatology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Neonatology, Maulana Azad Medical College and Lok Nayak Janpratinidhi Hospital
Central
DELHI
110002
India |
| Phone |
9870568316 |
| Fax |
|
| Email |
dasemilee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology, Maulana Azad Medical college and Lok Nayak Janpratinidhi Hospital, Department of Neonatology, Delhi Central , India, pin code : 110002 |
|
|
Primary Sponsor
|
| Name |
Emilee Das |
| Address |
Department of Neonatology, Maulana Azad Medical College and Lok Nayak Janpratinidhi Hospital, Delhi Central, India, pin code : 110002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Emilee Das |
Maulana Azad Medical College and Lok Nayak Janpratinidhi Hospital |
Department of Neonatology inborn and outborn units, Maulana Azad Medical College and Lok Nayak Janpratinidhi Hospital, Central Delhi, India, Pin code : 110002
Central
DELHI |
9870568316
dasemilee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
After recruitment as control arm no protocolised cyclical positioning will be done |
Control arm babies will get all standard ventilator care |
| Intervention |
Cyclical protocolised position change of the baby |
After recruiting as intervention arm, the ventilated neonates position will be changed every 6 hours from supine position to right lateral then to prone position after 6 hours then to left lateral position then again back to supine after 6 hours |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Babies with gestational age of less than 34 weeks , ventilated more than 3 days at our institute anytime before 29 days of age. |
|
| ExclusionCriteria |
| Details |
Extreme prematurity (28 days), Babies with Pulmonary artery hypertensiondiagnosed before enrolment, Babies operated or to be operated for any surgical cause, Severe congenital malformation, Fragile bone disease (eg. Osteogenesis imperfecta), Clinical suspicion of Intracranial haemorrhage within 1st 3 days of life , Birth trauma(eg. fracture bone) |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total ventilator days including both invasive and non-invasive ventilation |
Prior to discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Infection/sepsis (need for antibiotics after enrolment) |
Before discharge |
| Ventilator associated pneumonia |
Before discharge |
| Pneumothorax |
Before discharge |
| Intraventricular hemorrhage |
Before discharge |
| Duration of Nicu stay in days |
Before discharge |
| Duration of only oxygen therapy after weaning |
Before discharge |
| Mortality |
Death |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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
|
In my study, in the preinitiation phase, all healthcare professionals will be trained for positioning maneuvers in intubated neonates and those on non invasive ventilation and trained to identify and tackle any adversities associated. We will include neonates less than 34 weeks of gestation and ventilated at inborn or outborn unit for atleast 3 days. Exluded babies will have extreme prematurity (less than 28 weeks of gestation, Persistant pulmonary hypertension of newborn, Babies operated or to be operated on for any surgical cause, Fragile bone disease like osteogenesis imperfecta, Intracranial hemorrhage , birth trauma like fracture bone. We will take consent from parents in the next stage followed by Randomization by computer generated block of size 4 and allocation concealment will be done by serially numbered opaque envelope. We will determine baseline characteristics of enrolled babies and then start the intervention that is protocolised cyclical positioning after 3 days of ventilation. Primary outcome will be total invasive and noninvasive ventilator days and in secondary outcome we will see total number of babies with ventilator associated pneumonia, extubation failure, Duration of nicu stay in days, Duration of only oxygen therapy post weaning, sepsis defined as use of antibiotics post enrollment, intraventricular hemorrhage, pneumothorax and mortality. Then we will do the intention to treat analysis and per protocol analysis. Our total sample size is 64 and 32 babies in each arm. Aim of my study is to prove that efficacy of protocolised change in position of ventilated neonate will reduce ventilator days significantly . My total study duration is one year and will be conducted in both inborn and outborn unit of LNJP hospital associated with Maulana Azad Medical College. In previous studies done on preterm neonates, full chest physiotherapy was performed including percussion, vibration along with position change which reduced ventilator days by 7 days. As full physiotherapy is not feasible for every preterm babies we want to do only cyclical position change every 6 hourly that is from supine to right lateral then prone positioning then left lateral and back to supine till baby is off ventilator. We want to show that only this maneuver should reduce ventilator dats by 33 percent of 7 days that is atleast 3 days. Which has not been done in prior studies in literature, hence fulfilling the purpose of my study . |