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CTRI Number  CTRI/2018/01/011116 [Registered on: 02/01/2018] Trial Registered Retrospectively
Last Modified On: 02/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   comparison of two types of ventilation modes given through ventilator after treating with surfactant (medicine)needed to breath easily in premature infants 
Scientific Title of Study   Comparison of nasal continuous positive pressure versus nasal intermittent positive pressure ventilation in preterm infants on the need for intubation in minimally invasive surfactant therapy approach. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrudula M Sawadkar Dr Leslie Edward Lewis 
Designation  Student, Msc. RT 
Affiliation  School of Allied Health Sciences, Manipal 
Address  NICU, kasturba Hospital, Manipal, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  8975744517  
Fax    
Email  mrudula.sawadkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Leslie Edward Lewis 
Designation  Associate Professor, Dept. of Pediatrics, KMC, Manipal 
Affiliation  Kasturba Medical College, Manipal, Karnataka, 576104 
Address  NICU, kasturba Hospital, Manipal, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  9449208476  
Fax    
Email  leslielewis1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mrudula M Sawadkar Dr Leslie Edward Lewis 
Designation  Student, Msc. RT 
Affiliation  School of Allied Health Sciences, Manipal 
Address  NICU, kasturba Hospital, Manipal, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  8975744517  
Fax    
Email  mrudula.sawadkar@gmail.com  
 
Source of Monetary or Material Support  
neonatal intensive care unit, KH, manipal 
 
Primary Sponsor  
Name  Kasturba Hospital 
Address  Madhav Nagar, Manipal, karnataka-576104  
Type of Sponsor  Private medical college 
 
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 
Mrudula M Sawadkar  Neonatal Intensive Care Unit  Kasturba Hospital Manipal
Udupi
KARNATAKA 
8975744517

mrudula.sawadkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee, Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Neonatal Respiratory Distress Syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  4.00 Day(s)
Gender  Both 
Details  will be selecting babies born at 28-32 weeks of gestation, presented with signs of respiratory distress (Tachypnea, flaring of nostrils, grunt and retractions) 
 
ExclusionCriteria 
Details  1.Neonates requiring intubation in the delivery room.
2.Neonates with major congenital malformations.
3.Out born neonates.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Need for intubation and mechanical ventilation within the first 72 hours of life.  1. Need for intubation and mechanical ventilation within the first 72 hours of life. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Duration of non- invasive ventilation.
2. Duration of invasive ventilation.
3. Duration of supplemental oxygenation.
4. Overall rate of intubation.
5. Incidence of pneumothorax.
 
at any point of time within NICU stay 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/05/2017 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  


This is a prospective observational study involving collection of data of standard of care therapy [non-invasive ventilation(NCPAP, NIPPV)] and does not involve any additional intervention. As studies done on comparison between these two modes of non-invasive ventilation within MIST are limited in India, it has been taken as thesis topic.

Study period : 1 year (May2017- April 2018)

Sample size : 40 infants in each group

Statistical methods : Previous data suggests that 40% of the preterm infants who receive early CPAP and rescue surfactant for RDS needed invasive ventilation within first 72h of life. Predicting a 20% absolute reduction in the need for invasive ventilation with MIST. For a power of 80%, with two- sided significance level of an α error rate of 5%, we calculated sample size of 40 infants in each group.

Continuous variables will be presented as median using- independent sample t- test, independent groups using Mann- Whitney U test and Categorical variables using χ2 test ,presented as number and percentage. In addition to p value of the primary outcome, results will be given as differences and 95% confidence intervals. A p value <0.05 was considered statistically significant.

Neonate details like date of birth, admission, gestational age, birth weight, gender, Apgar score, prenatal steroid administration, mode of delivery, basic vitals on admission are to be recorded. Downe’s score for respiratory distress will be assessed every 4 hours for the first 48 hours.

Each infant will be assigned NCPAP or NIPPV according to concerned neonatologist’s opinion and will be started within 30 min of birth.

Both NCPAP and NIPPV will be delivered by neonatal ventilator (Drager Babylog 8000) via nasal mask. NCPAP pressure will be set at 5–6 cm H2O, and NIPPV will be set in a non-synchronised mode at 20–30 bpm, with PEEP of 5–6 cm H2O and PIP of 15–20 cm H2O. FiO2 will be titrated at 0.21–0.50 to maintain an oxygen saturation level of 90%–95%, as measured via pulse oximeter.

Under non-invasive ventilation surfactant will be administered as a rescue therapy if the infant requires FiO2 > 0.4 to maintain the target saturation level of 90-95%.A dose of 4ml/kg (100mg /kg of phospholipid) Survanta® (beractant)] or 2.5ml/kg (200mg/kg of phospholipid) Curosurf®, Chiesi Farmaceitici S.p.A, Parma, Italy] of surfactant will be administered within the MIST approach via a gastric tube placed in the trachea in patients who met the criteria for surfactant administration

Pulse oximeter saturation, heart rate and respiratory rate and blood pressure will be monitored continuously by the Philips IntelliVue Patient Monitor MP20 monitor.There will be a continuous monitoring of the number of days requiring respiratory support till the neonate is off oxygen support.There will be no additional intervention involved in this observational studyInfants who failed under NCPAP/NIPPV and required surfactant therapy will be administrated surfactant via the endotracheal tube if necessary, as they will be already intubated. The initial mode of nasal support (NIPPV or NCPAP) will be continued until the patient is weaned from it in accordance with our NICU practice. Infants supported with NCPAP will not allowed to be switched to NIPPV when the severity of their respiratory symptoms increased. Infants intubated in the first 72 h of life will be extubated to their allocated mode.

   



 
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