FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045204 [Registered on: 05/09/2022] Trial Registered Prospectively
Last Modified On: 22/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Administration of surfactant by thin catheter (LISA) using video laryngoscope to decrease pain in neonates  
Scientific Title of Study   Less invasive surfactant administration (LISA) using video laryngoscope to decrease pain in neonates: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mude Praneetha 
Designation  DM Senior resident  
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Neonatology AIIMS Bhubaneswar Sijua, Patrapada Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7358904840  
Fax    
Email  m.prani8396@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tapas Som 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Neonatology AIIMS Bhubaneswar Sijua, Patrapada Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884114  
Fax    
Email  neonat_tapas@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Mude Praneetha 
Designation  DM Senior Resident  
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Neonatology AIIMS Bhubaneswar Sijua, Patrapada Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7358904840  
Fax    
Email  m.prani8396@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bhubaneswar 
 
Primary Sponsor  
Name  Mude Praneetha 
Address  Department of Neonatology, AIIMS Bhubaneswar Sijua, Patrapada Bhubaneswar 
Type of Sponsor  Other [Self] 
 
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 
Mude Praneetha  AIIMS Bhubaneswar  NICU Department of Neonatology
Khordha
ORISSA 		 7358904840

m.prani8396@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Administration of surfactant by LISA technique using conventional laryngoscope   Surfactant administration by the LISA technique will be done using conventional laryngoscope Surfactant (Neosurf) will be administered at a dose of 5ml/kg slowly over 5-10 minutes while monitoring heart rate and saturation  
Intervention  Administration of surfactant by LISA technique using video laryngoscope  Surfactant administration by LISA technique will be done using a video laryngoscope by personnel who has either assisted five or performed two intubations or surfactant administration by LISA technique Surfactant (Neosurf) will be administered at a dose of 5ml/kg slowly over 5-10 minutes while monitoring heart rate and saturation  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  Preterm neonates requiring rescue surfactant, i.e., FiO2 requirement > 0.3 on CPAP pressure of at least 6 cm H2O 
 
ExclusionCriteria 
Details  Neonates who require intubation in the delivery room for stabilization


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
FANS score (Faceless acute neonatal pain scale) will be assessed to evaluate procedural pain in neonates below 35 weeks of gestational age while administering surfactant by LISA technique using any of the two laryngoscopes (video vs. conventional)  1. 5 minutes before procedure (baseline)
2. Immediately post procedure
3. 5 minutes post procedure
4. 10 minutes post procedure  
 
Secondary Outcome  
Outcome  TimePoints 
Time taken to complete
the procedure
 		 At the time of procedure 
Number of attempts to complete the procedure successfully  At the time of procedure  
To record adverse events during the procedure  At the time of procedure 
Incidence of intraventricular hemorrhage  on day 7 of life  
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/09/2022 
Date of Study Completion (India) 03/06/2024 
Date of First Enrollment (Global)  08/09/2022 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 

Respiratory morbidities are common in preterm neonates. The incidence of respiratory distress syndrome (RDS) increases with decreasing gestational age. RDS is a disease of surfactant deficiency that leads to diffuse atelectasis and alveolar collapse after birth. For the management of RDS, apart from supportive care, surfactant therapy plays a significant role in decreasing mortality and morbidity. Previously, standard practice for surfactant administration was through an endotracheal tube following intubation. Following this, INSURE technique was developed (intubate- administer surfactant-extubate to CPAP), which reduced the incidence of Bronchopulmonary dysplasia. However, INSURE technique was associated with an increased risk of pneumothorax and BPD. Subsequently a new technique of surfactant administration was developed, using a fine catheter placed in the trachea under a laryngoscope with the neonate breathing spontaneously on CPAP known as less invasive surfactant administration (LISA) which reduces the need for mechanical ventilation in neonates with RDS and the composite outcome of death and BPD at 36 weeks among survivors.

Though less invasive surfactant administration (LISA) is minimally invasive, the use of a direct laryngoscope might be painful. Painful procedures in premature infants cause marked fluctuations in intracranial pressure and may lead to intraventricular hemorrhage/ periventricular leukomalacia. Pharmacological measures like the use of sedatives or analgesics to reduce procedural pain have higher occurrence rates of prolonged desaturations and apnea requiring positive pressure ventilation.
Therefore we plan to assess the use of a video laryngoscope for surfactant administration to reduce pain which is assessed by faceless acute neonatal pain scale (FANS) in neonates compared to the use of a conventional laryngoscope.

FANS score, a multimodal pain assessment scale that evaluates behavioral items, i.e., body movements, vocal expression, and physiological items, i.e., variation in heart rate, bradycardia Score, or desaturations on a 0 (no pain) scale to 10 (maximal pain). This scale was developed to assess acute pain in neonates when the face is not accessible, which is common in current neonatology practice. The interpretation of FANS score is as 0 - no pain, ≤ 4 - moderate pain, 10 - maximal pain.

All neonates admitted to NICU during the study period would be screened for eligibility and those neonates fulfilling inclusion criteria would be enrolled. After satisfying the inclusion criteria, the neonates will be recruited for the study after taking the informed consent of the parents. Demographic details, baseline information like period of gestation (POG), birth weight, APGAR scores at 1min and 5 min of life, resuscitation details (need for intubation in the delivery room), respiratory support after birth (CPAP/ NIMV/IMV), pressures delivered on respiratory support, FiO2 requirement. Preterm neonates requiring FiO2 >0.3 on CPAP pressure of at least 6cm of H2O will be administered surfactant by LISA technique. Before administering surfactant by LISA, randomization of eligible neonates would be done as described. Stratification will be done based on gestational age < 32 weeks and ≥ 32 weeks. Subsequently, simple randomization will be done for each stratum into two groups, one being interventional and the other being the control group using the opaque sealed envelopes (SNOSE) technique. No sedatives or analgesics will be given pre or post procedure.

LISA technique for surfactant administration

In a spontaneously breathing neonate, while continuing delivery of CPAP via a nasal mask, a laryngoscope with an appropriate size blade (conventional or video laryngoscope) is used to visualize the vocal cords and insert surfcath (a thin catheter used for surfactant administration) till the disappearance of the black mark at vocal cords and then remove the laryngoscope keeping the catheter in place. Close the mouth and take a note of the marking present at the lip of the baby to prevent catheter displacement. Then attach prefilled syringe with the appropriate dose (i.e., 5ml/kg of Neosurf) of surfactant (Neosurf – a bovine surfactant) to the proximal end of surfcath and inject the total dose slowly while monitoring heart rate and saturation. Ensure that all the surfactant has been emptied from the tube, and then remove the surfcath.

Intervention arm:

In this group, surfactant administration by LISA technique will be done using a video laryngoscope by personnel who has either assisted five or performed two intubations or surfactant administration by LISA technique

Control arm:

Surfactant administration by LISA technique using conventional laryngoscope would be performed as explained above.

Faceless acute neonatal pain score, a validated tool to assess acute pain in preterm neonates, would be used to determine pain 5 minutes before the procedure, immediately, 5min and 10minutes after the procedure. The procedure would be video recorded, where behavioral parameters (limb movements, vocal expression) can be recorded, for physiological parameters (heart rate variation and acute discomfort) data would be collected from the multipara monitor attached to the neonate before and during and after the procedure. The recorded video (behavioral parameters) would be interpreted by the investigator and different personnel not present at the time of the procedure and would score using FANS score as 0 – no pain, <4 - moderate pain, 10-maximal pain. If a neonate requires surfactant administration twice, then it would be taken as two different observations. 

Secondary outcome variables i,e time taken to complete the procedure, number of attempts to complete the procedure successfully, and adverse events during the procedure would be recorded manually from monitoring sheets. Incidence of IVH would be documented on day 7 of life using cranial ultrasonography by volpe’s grading 

Appropriate statistical analysis will be done at the end of study.



 
Close