Less invasive surfactant administration versus
intubation for surfactant delivery in preterm
infants
with respiratory distress syndrome: a
systematic
review and meta-analysis
Research Plan
A. Rationale
Less-invasive surfactant administration (LISA) is a procedure used to
administer surfactant through a thin catheter instead of a tube . This procedure
along with Continuous Positive Airway pressure (CPAP) helps avoid the use of
mechanical ventilation and reduce the risk of bronchopulmonary dysplasia.
INtubation, SURfactant, Extubation (INSURE) is a procedure that is
administered via endotracheal intubation, along with manual lung ventilation
(leone, 2013).
Respiratory distress syndrome (RDS) is a disorder that affects the breathing of
a newborn, it usually occurs in preterm infants (Respiratory Disease Syndrome,
2019). The lack of surfactant that coats the alveoli may lead to the alveoli closing. If
left untreated, pediatric respiratory distress syndrome can cause brain damage,
organ damage or death (Wikipedia, 2020).
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B. Research Question,Hypotheses, Goals, Expected Outcomes
Research Question: Can LISA help reduce the risk of infants with RDS developing
neurodevelopmental disorders?
Hypotheses:
Alternative - LISA has a significant effect in reducing the risk of BPD and Death in
preterm infants.
Null - LISA does not have any significant effect in reducing the risk of preterm
infants developing BPD and lead to death.
Cause and Effect - If Lisa is administered along with CPAP then it would reduce the
risk of BPD and death.
Goals:
A systematic review of randomised controlled trials (RCTs) comparing LISA with the
standard method of surfactant delivery for clinical outcomes.
Expected Outcome:
LISA is a much effective method for surfactant delivery than the other standard
method
C. Procedure
● Search strategy
The research librarian in collaboration with the research team will conduct
structured searches on subject headings and keywords for concepts related to
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surfactant application in preterm infants. The initial search will be conducted
employing the following electronic databases: Ovid Medline (1946 to date),
Cochrane Central Register of Controlled Trials (CENTRAL) via Cochrane Library
(from inception to date) and Ovid Embase (1980 to date).
● Study selection and data extraction
Reviewers will independently search for eligible studies, discrepancies will be
resolved through discussion with a third reviewer. Studies will be included if they
met the following criteria: randomised sequence generation, compared LISA
technique with the standard technique of surfactant delivery involving
endotracheal intubation and measured one or more of the following outcomes:
death and/or BPD at 36-week gestation, need for mechanical ventilation or any
other neonatal morbidities. Data will be extracted by one reviewer using a
standardised form and check independently for accuracy by two other reviewers.
Primary authors of the included studies will be contacted for clarifications and
additional information
● Assessment of bias
Methodological quality will be addressed per the Cochrane risk of bias tool, 25
which includes items for adequacy of random sequence generation, allocation
concealment, blinding of the caregivers and the assessors, incomplete outcome
data reporting or selective reporting. Discrepancies will be resolved through
discussion and consensus among the review team.
D. Risk and precautionary measures
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Risk of bias assessment
Studies that will be gathered will be screened through different measures to avoid
bias and inaccuracy.
E. Data analysis
Data will be analysed using RevMan V.5.3. An a priori sensitivity analysis will be
planned for studies that explicitly state InSurE technique as the method of
surfactant delivery for control group. The study will be reported according to the
PRISMA guidelines. I2 statistic will be calculated for each analysis to quantify
heterogeneity across studies. If there wilp be substantial (I2 > 50%) heterogeneity
detected, the potential cause for its existence will be explored and further
sensitivity analyses will undergo.
F. Bibliography
Respiratory Disease Syndrome. (2019, April 9). National Lung, Heart and Blood
Institute. [Link]
syndrome#:~:text=Respiratory%20distress%20syndrome%20(RDS)%20is,before
%2028%20weeks%20of%20pregnancy.
Wikipedia. (2020, October 1). Pulmonary Surfactant.
[Link]
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Leone, F. (2013, April). Efficacy of INSURE during nasal CPAP in preterm infants with
respiratory distress syndrome. Pubmed.
[Link]
Bhayat, Shetty, S. S. (2020). Less-invasive surfactant administration. Paediatrics and
Child Health, 1. [Link]