| 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 |
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NIMS University Rajasthan, Jaipur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, |
|
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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
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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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
|
|
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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 |
|
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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 |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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; P 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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