1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. 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.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [docvvt_13@hotmail.com].
   


6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-01-2030?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

What is already known:

In preterm neonates RDS due to surfactant deficiency has been managed with intratracheal surfactant administration followed by invasive mechanical ventilation or extubation to non-invasive respiratory support in the form of non-synchronized nasal ventilation (NIV) or nasal continuous positive airway pressure (nCPAP) i.e. intubate, surfactant administration, extubation (INSURE) technique. Endotracheal intubation and positive pressure ventilation is the most important risk factor for unfavorable respiratory outcome in preterm neonates most notably BPD. With evolving management paradigms, NIV or nCPAP is preferred in premature infants. However nCPAP failure because of RDS especially in the most immature infants prompted search for a method for delivering surfactant in a less invasive manner (1). resulting in the development of the less invasive surfactant administration (LISA) technique with the aim to effectively provide an adequate dose of surfactant while the infant is breathing spontaneously with the support of nCPAP (2,3).

What more is required to be known: There is very limited and inconclusive evidence of LISA technique on short-term respiratory benefits in moderate to extreme preterm neonates. There are no indexed high-quality published studies on this from our country. This study would create evidence pertaining to decision for adapting LISA technique in neonatal intensive care units (NICUs) in our setting.

Why this study is required: To evaluate LISA technique as a management modality for management of preterm RDS in moderate to extreme preterm neonates and to determine the short-term respiratory outcomes compared to currently followed techniques of surfactant administration and continued ventilation and INSURE. Additionally, the study will also propose a decision making algorithm for case selection of preterm neonates with RDS suitable for LISA technique.

References:

1.     Dargaville PA, Gerber A, Johansson S, et al. Australian and New Zealand Neonatal Network. Incidence and outcome of CPAP failure in preterm infants. Pediatrics 2016; 138: pii: e20153985.

2.     Kribs A, Pillekamp F, Hunseler C, et al. Early administration of surfactant in spontaneous breathing with nCPAP: feasibility and outcome in extremely premature infants (postmenstrual age 27 weeks). Paediatr Anaesth 2007; 17:364–369.

3.     Herting E, Hartel C, Gopel W. Less invasive surfactant administration (LISA): chances and limitations. Arch Dis Child Fetal Neonatal Ed 2019; 104: F655–F659.