Respiratory monitoring during LISA in the delivery suite
Research type
Research Study
Full title
Respiratory physiological monitoring during less invasive surfactant administration (LISA) in the delivery suite
IRAS ID
257364
Contact name
Anne Greenough
Contact email
Sponsor organisation
The R&I Office
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
Nowadays many prematurely born infants do not routinely require a breathing tube, or intubation, for support at birth as they can breath adequately by themselves on continuous positive pressure support (CPAP) via a face-mask or nasal prongs. Due to increasing respiratory distress, however, they often later require intubation for delayed surfactant administration. Surfactant helps to reduce the surface tension of the lungs and therefore helps the lungs to expand efficiently and not to collapse at the end each breath. Prematurely born infants are lacking in their own surfactant production and hence benefit from an artificial form of this molecule which is routinely given at birth, or in the first few postnatal days. Previously surfactant has been given via a breathing tube to reach and act on the lungs.
We know from previous research that intubating infants or giving surfactant later rather than soon after birth is associated with adverse outcomes such as the development of chronic lung disease of prematurity. Newer modes of administering surfactant have therefore been developed - one of which is the less invasive surfactant administration (LISA) technique. LISA enables surfactant to be given very soon after birth, in those infants who are breathing adequately, without the need for inserting a breathing tube. LISA uses a thin catheter, much smaller than a breathing tube, to administer surfactant to the lungs and avoids mechanical breaths and potential lung damage as a result.
What is currently unknown, and hence why this research is being proposed, is how the lungs respond to surfactant therapy by LISA when given very soon after birth in the delivery suite. We aim to monitor the how the lungs work and respond to LISA by comparing respiratory function before and after, alongside respiratory outcomes in the first twenty-four hours of life.
Summary of Results
One hundred one infants received surfactant via less invasive surfactant administration (LISA) in the delivery room. One infant was excluded as postnatally diagnosed to have Trisomy 21 associated with congenital cardiac anomaly. One infant was excluded from the study as the parents did not give consent. Ninety-nine infants were included in the study. Eleven infants less than 30 weeks of gestation received LISA in the delivery room.
Ninety-nine infants were recruited into the study with a median gestational age of 32+4 (range: 27+0– 34+6) weeks and birth weight of 1.68 (range:0.7-2.82) kg. The surfactant was administered via LISA at a median age of 22 (range:6-56) minutes over a median duration of 180(range:120-360) seconds. The most common side effect was desaturation (47.5%). Three infants had pneumothorax of which two required chest-drain insertion as well as mechanical ventilation - one infant had pneumothorax following LISA and the second one after six hours of mechanical ventilation. Fourteen infants (14.1%) needed a second dose of surfactant due to either significant work of breathing with respiratory distress or high oxygen requirement which was given via endotracheal intubation.
Respiratory monitoring
The respiratory rate and minute ventilation (p < 0.001) decreased after LISA administration, as did the tidal volume (p < 0.001) and Fraction of inspired oxygen (FiO2) (p < 0.001); there was an increase in the SpO2/FiO2 ratio (p < 0.001). The FiO2 (p < 0.001) and the SpO2/FiO2 ratio (p < 0.001) improved two hours after LISA administration. LISA failure was associated with a higher (median) FiO2 requirement pre-LISA (p =0.02) and a lower SpO2/FiO2 ratio (p = 0.04).Outcomes
Compared to historical controls, LISA administration was associated with a significant reduction in the need for mechanical ventilation within 72 hours (20.2% versus 56.6%) after adjusting for gestational age, birth weight and Apgar score at 5 minutes [adjusted p<0.001, OR: 0.17(0.09-0.36)]. Similarly, LISA administration was associated with a reduction in the need for mechanical ventilation at any point during the hospital stay (25.3% versus 56.6%, p<0.001) and shorter duration of invasive ventilation (0 versus 1 day, p<0.001). The infants who received LISA had a reduced incidence of moderate to severe bronchopulmonary dysplasia (BPD) (8.2% versus 20.2%, p=0.02). Furthermore, the median costs of neonatal intensive care stay (£1218 versus £2436, p=0.03) and median total cost of neonatal stay (£12888 versus £17240, p=0.04) were lower in infants who received LISA.REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0044
Date of REC Opinion
7 May 2019
REC opinion
Further Information Favourable Opinion