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 |
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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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Neonatal Respiratory Distress Syndrome, |
|
Intervention / Comparator Agent
|
|
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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