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CTRI Number  CTRI/2024/04/065538 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants 
Scientific Title of Study   Nasal intermittent positive pressure ventilation (NIPPV) versus nasal Continuous positive airway pressure (NCPAP) as a primary respiratory support for preterm infants (≤34 weeks) – A Randomized Control 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  Gurnoor Singh 
Designation  DM Neonatology Resident 
Affiliation  National Institute of Medical Science and Research, Jaipur, Rajasthan 
Address  First floor, Department of Neonatology, near Neonatal Intensive care unit, NIMS Hospital, Jaipur Rajasthan.

Jaipur
RAJASTHAN
303121
India 
Phone  8837714140  
Fax    
Email  drgurnoorsingh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gunjana Kumar 
Designation  Assistant Professor  
Affiliation  National Institute of Medical Science and Research, Jaipur, Rajasthan 
Address  First floor, Department of Neonatology, near Neonatal Intensive care unit, NIMS Hospital,Jaipur, Rajasthan.

Jaipur
RAJASTHAN
303121
India 
Phone  7073077130  
Fax    
Email  gunjanakumar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gunjana Kumar 
Designation  Assistant Professor  
Affiliation  National Institute of Medical Science and Research, Jaipur, Rajasthan 
Address  First floor, Department of Neonatology, near Neonatal Intensive care unit, NIMS Hospital,Jaipur, Rajasthan.

Jaipur
RAJASTHAN
303121
India 
Phone  7073077130  
Fax    
Email  gunjanakumar@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Medical Science and Research, Jaipur, Rajasthan, India.Pin code 303121 
 
Primary Sponsor  
Name  National Institute of Medical Science and Research Jaipur Rajasthan India  
Address  First floor, Room no 1, Department of Neonatology, near Neonatal Intensive care unit, NIMS Hospital, Jaipur Rajasthan. India, Pin code 303121 
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 
Dr Gurnoor Singh  National Institute of Medical Science and Research, Jaipur, Rajasthan, India   Room number 1, First floor, Department of Neonatology, near Neonatal Intensive care unit, NIMS Hospital, Jaipur Rajasthan.
Jaipur
RAJASTHAN 
8837714140

drgurnoorsingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NIMS University Rajasthan, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nasal continuous positive airway pressure(NCPAP)  Preterm (gestational age ≤ 34 weeks)presenting to NICU within 6 hours of birth with Respiratory distress, defined as Silverman Andersen Respiratory Severity Score (SAS score ≥3/10) will be provided with Nasal continuous positive airway pressure(NCPAP) as a primary respiratory support. 
Intervention  Nasal intermittent positive pressure ventilation (NIPPV)  Preterm (gestational age ≤ 34 weeks)presenting to NICU within 6 hours of birth with Respiratory distress, defined as Silverman Andersen Respiratory Severity Score (SAS score ≥3/10) will be provided with Nasal intermittent positive pressure ventilation (NIPPV) as a primary respiratory support.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  Neonates fulfilling all the following criteria
1. Preterm infants (gestational age ≤ 34 weeks)
2. Presenting to NICU within 6 hours of birth
3. Respiratory distress, defined as Silverman Andersen Respiratory Severity Score (SAS
score ≥3/10)
4. Babies whose parents/Guardians have given informed consent 
 
ExclusionCriteria 
Details  Anyone of the following
1. Major congenital anomaly (antenatally diagnosed or visible at birth)
2. Presence of severe Hemodynamic instability before randomization. [Vasopressor
inotrope index ≥ 10 that is dopamine (≥ 10 mcg/kg/min), dobutamine (≥ 10 mcg/kg/min), epinephrine (≥ 0.1 mcg/kg/min), norepinephrine (≥ 0.1 mcg/kg/min), vasopressin (≥ 0.001 IU/kg/min) and milrinone (≥ 0.1 mcg/kg/min)]
3. Baby intubated at or before admission to NICU
 
 
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 assess the need for intubation within the first 72 hours after randomization (within 6 hours after birth) in preterm infants(≤ 34 weeks) with respiratory distress receiving either NIPPV or CPAP.
 
Discharge from hospital or death
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Need for surfactant
2. Proportion of neonates requiring mechanical ventilation
3. Proportion of neonates requiring non invasive ventilation.
4. Duration of primary respiratory support.
5. Duration of mechanical ventilation.
6. Duration of non invasive ventilation
7. Duration of oxygen therapy
8. Incidence of sepsis
9. Incidence of air leak
10. Incidence of Pulmonary Hemorrhage
11. Incidence of BPD, HsPDA, IVH Grade 3 or more, NEC, ROP
12. Time to reach full feeds
13. Duration of hospital stay
14. All cause mortality 
DISCHARGE OR DEATH  
 
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   N/A 
Date of First Enrollment (India)   24/04/2024 
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 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  

Prematurity is associated with respiratory distress due to variable reasons including immature lungs with inadequate surfactant production and relatively weak respiratory muscles with increased lung compliance ultimately leading to atelectasis, poor functional residual capacity, and lung collapse. In the past, preterm infants with signs of moderate or severe respiratory distress were intubated and mechanically ventilated. This invasive approach resulted in inflammation of the lungs in the short term and impaired development and scarring known as bronchopulmonary dysplasia (BPD) in the long term. Efforts to decrease rates of BPD in the surfactant/antenatal steroid era have led to increased use of non-invasive respiratory support for even the most immature infants. Non-invasive ventilation is preferred to use instead of invasive mechanical ventilation. Nasal continuous positive airway pressure (NCPAP) and nasal intermittent positive pressure ventilation (NIPPV) are the most commonly used non-invasive respiratory support modalities in neonates with respiratory distress compared with others such as high-flow nasal cannula, nasal high-frequency oscillatory ventilation, neutrally adjusted ventilator assist. NCPAP reduces upper airway resistance, helps to establish functional residual capacity, stabilizes the chest wall, and preserves endogenous surfactant. NIPPV was also studied as another method for the RDS treatment. It is a time-cycled pressure-limited ventilation mode, that superimposes an intermittent peak pressure on NCPAP. In addition to the benefits of NCPAP, NIPPV improves ventilation in apnea by providing a backup rate and using sufficient peak inspiratory pressure. Due to the use of higher mean airway pressure, NIPPV results in better alveolar recruitment and improved carbon dioxide clearance. 

The majority of clinical trials in preterm infants have compared NIPPV with CPAP as either the primary mode of treatment for neonatal respiratory distress syndrome (RDS), or after extubation. Of these trials, Kirpalani’s NIPPV Trial dominates the literature. This large, pragmatic trial differs from the smaller studies in that it recruited a heterogeneous study population and permitted a variety of devices to deliver NIPPV, including some that delivered synchronized pressure changes. Although pragmatic, the considerable degree of methodological and clinical heterogeneity makes the interpretation of pooled trial results difficult. The primary outcome, death or bronchopulmonary dysplasia (BPD) occurred in 38.4% of randomized neonates on NIPPV and in 36.7% of neonates with CPAP (adjusted odds ratio, 1.09; 95% confidence interval [CI], 0.83–1.43; 5 .56). There were no significant differences between NIPPV and CPAP in the individual components of death or BPD. Majority of clinical trials in preterm infants compared NIPPV with CPAP as a modality after extubation, In this study, we aimed to compare NCPAP vs. NIPPV as an initial treatment of Respiratory distress in terms of prematurity-related morbidities and mortality. This study aim to compare nasal intermittent positive pressure ventilation (NIPPV) versus continuous positive airway pressure (CPAP) as primary respiratory support for preterm infants (≤ 34 weeks) with primary outcome  to assess the need for intubation within the first 72 hours after randomization (within 6 hours after birth) in preterm infants(≤ 34 weeks) with respiratory distress between NIPPV and CPAP.

 

 
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