| CTRI Number |
CTRI/2025/02/079881 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing efficacy and safety using bovine vs porcine surfactants by thin catheter method in preterm infants with respiratory distress syndrome |
|
Scientific Title of Study
|
Comparison of bovine vs porcine surfactants by less invasive surfactant administration technique (LISA) for preterm infants ≤ 30 weeks with respiratory distress syndrome (RDS): a randomized 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 |
Dr Meena Kadiyala |
| Designation |
DM Neonatology resident |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Neonatology, Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, SH 49A, Kelambakkam, Chengalpattu district, Kancheepuram, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8501077299 |
| Fax |
|
| Email |
kadiyalameena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Giridhar Sethuraman |
| Designation |
Professor of Neonatology |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Neonatology, Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, SH 49A, Kelambakkam, Chengalpattu district, Kancheepuram, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841027228 |
| Fax |
|
| Email |
giridharsethu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giridhar Sethuraman |
| Designation |
Professor of Neonatology |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Neonatology, Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, SH 49A, Kelambakkam, Chengalpattu district, Kancheepuram, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841027228 |
| Fax |
|
| Email |
giridharsethu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, SH 49A, Kelambakkam, Chengalpattu district, Kancheepuram, Tamil Nadu, India - 603103. |
|
|
Primary Sponsor
|
| Name |
Dr Meena kadiyala |
| Address |
Department of Neonatology, Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, SH 49A, Kelambakkam, Chengalpattu district, Kancheepuram, Tamil Nadu, India - 603103 |
| Type of Sponsor |
Other [self] |
|
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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 Meena kadiyala |
Chettinad Hospital and Research Institute |
Department of Neonatology, block-c, ground floor
Kancheepuram
TAMIL NADU |
8501077299
kadiyalameena@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research(CARE IHEC-I) |
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: P220||Respiratory distress syndrome of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bovine surfactant(Survanta/Neosurf) administration by LISA method |
Preterm infants less than or equal to 30 weeks with features of respiratory distress syndrome will be given bovine surfactants(either Survanta or Neosurf) within 6 hours of birth by less invasive surfactant administration method(LISA) while continuing the baby on non-invasive ventilation(NIV)
The dose of Survanta is 100mg/kg (4ml/kg) given via intratracheal route with the use of thin catheter; repeat doses are given as per manufacturer recommendations which are maximum upto 3 repeat doses(repeat dose given after 6 hours of previous dose); dose of repeat course is same as 1st dose.
The dose of Neosurf is 135 mg/kg (5ml/kg) given via intratracheal route with the use of a thin catheter; repeat doses are as per manufacturer recommendations which are maximum upto 2 repeat doses (repeat dose given after 6 hours of previous dose); dose of repeat course is same as 1st dose. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Porcine surfactant(Poractant alfa) administration by LISA method |
Preterm infants less than or equal to 30 weeks with features of respiratory distress syndrome will be given porcine surfactant(Poractant alfa) within 6 hours of birth by less invasive surfactant administration method(LISA) while continuing the baby on non-invasive ventilation(NIV)
The dose of poractant alfa is 200mg/kg (2.5ml/kg) given via intratracheal route with the use of a thin catheter; repeat doses are given as per manufacturer recommendations which are maximum upto 2 repeat doses (repeat dose given after 6-12 hours of previous dose); dose of repeat course is 100 mg/kg.
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|
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Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
Infants born at 26 0/7 to 30 0/7 weeks of gestation with features suggestive of RDS on nasal CPAP (with Fio2 requirement more than 30%) within 6 hours after birth, as decided by the treating physician will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Infants who have life-threatening congenital anomalies or were considered non-viable
Infants with severe hemodynamic instability, poor respiratory efforts
Infants with Fio2 requirement less than 30%
Infants who require early intubation and ventilation at birth
Infants who were born after prolonged premature rupture of membranes (14 days prior to delivery).
Infants who have birth asphyxia (Apgar score of less than 7 at minute 5, umbilical cord pH less than 7, base excess (BE) more than -16)
Infants who have anomalies of the upper or lower airway or mandible precluding use of nasal CPAP
|
|
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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
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Requirement of intubation and mechanical ventilation within 72hours after birth post surfactant administration due to persistent respiratory distress with high FIO2 requirement (more than 40% ) on nasal CPAP (CPAP failure) |
Birth to 72 hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Severe adverse events during the LISA procedure defined as prolonged apnea more than 20 seconds with desaturation (SpO2 less than or equal to 80%) and/or bradycardia (HR less than 80 beats/min) requiring up to bag & mask ventilation or escalation to NIPPV support.
Transient adverse events during the LISA procedure like desaturation and/or bradycardia not compromising the baby and picking up to normal within few seconds
Surfactant reflux during and post procedure as noticed from OGT aspiration
|
During and post procedure |
Intubation within 7 days of life
Neonatal mortality within 28 days of life
Mortality till discharge
Requirement of redosing of surfactant
Duration of mechanical ventilation
Duration of CPAP/NIPPV
Pulmonary hemorrhage
Air leak syndromes (pneumothorax , pulmonary interstitial emphysema , pneumomediastinum)
Total duration of respiratory support
Moderate to severe bronchopulmonary dysplasia
Composite outcome of death and bronchopulmonary dysplasia |
Birth to discharge |
Patent ductus arteriosus requiring treatment (hs-PDA)
Culture confirmed bacterial / fungal sepsis
Necrotising enterocolitis (bell stage II or greater)
Intraventricular hemorrhage (IVH any grade)
Retinopathy of prematurity (ROP) requiring treatment
Total duration of hospital stay |
Birth to discharge |
|
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Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
03/02/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2029?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Respiratory distress syndrome (RDS) is the main cause of respiratory failure in preterm infants and its incidence differs depending on gestational age and birth weight. The best approach to treat RDS is the administration of delivery room CPAP followed by early selective surfactant administration for infants with worsening oxygenation and increasing work of breathing. European and American guidelines advise in favor of this strategy, which reduces mortality and bronchopulmonary dysplasia. Commonly available and widely used surfactants in India are Survanta/Beractant (bovine minced lung extract), Neosurf/BLES (bovine lung lavage surfactant), and Curosurf/Poractant alfa (porcine minced lung extract). A comparison of animal derived surfactants proved porcine surfactants to be superior over bovine surfactants in terms of efficacy and safety (Tridente et al 2019 systematic review). But this effect has not been well established with the current preferred method of surfactant administration i.e. LISA (less invasive surfactant administration) using a thin stiff catheter. All the previous studies where the LISA method was studied used porcine surfactant (poractant alfa/curosurf) for surfactant administration and bovine surfactants were not studied with this method. A recent study by Zamal et al has shown equivocal results with beractant when compared with poractant alfa by the LISA method and adverse events were not different between the two groups. However, the study concluded with Beractant to be a better option in LMIC in terms of cost. Surfactant administration through LISA has adverse effects of surfactant reflux which is expected to be higher with bovine surfactants which are of high volume (survanta 4ml/kg , neosurf 5ml/kg) compared to porcine surfactant (curosurf 2.5 ml/kg). Cost associated is more with porcine surfactant compared to bovine surfactants. If more data is available with bovine surfactants with this new method, it would be practical to use bovine surfactants in LMICs where cost also plays an important role. So, we have taken up this study to compare efficacy & safety of bovine surfactants vs porcine surfactant by LISA method.
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