Administration of surfactant by thin catheter (LISA) using video laryngoscope to decrease pain in neonates
- Conditions
- Respiratory distress syndrome of newborn,
- Registration Number
- CTRI/2022/09/045204
- Lead Sponsor
- Mude Praneetha
- 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 administrationIn 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 42
Preterm neonates requiring rescue surfactant, i.e., FiO2 requirement > 0.3 on CPAP pressure of at least 6 cm H2O.
Neonates who require intubation in the delivery room for stabilization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Number of attempts to complete the procedure successfully At the time of procedure Time taken to complete the procedure To record adverse events during the procedure At the time of procedure Incidence of intraventricular hemorrhage on day 7 of life
Trial Locations
- Locations (1)
AIIMS Bhubaneswar
🇮🇳Khordha, ORISSA, India
AIIMS Bhubaneswar🇮🇳Khordha, ORISSA, IndiaMude PraneethaPrincipal investigator7358904840m.prani8396@gmail.com