Minimally Invasive Surfactant Therapy (MIST)

Mentor
Walid Hussain, MD
Pediatrics

Description

We have developed a Quality improvement project to look at outcomes of neonates who receive surfactant via MIST vs those that have received it via InSurE (Intubate-surfactant-extubate) with the though that less positive pressure ventilation will improve neonatal outcomes. There will be chart reviewing done comparing the groups.

We have also developed a separate clinical research study looking at giving surfactant via MIST in the delivery room vs receiving in the NICU after meeting certain clinical criteria and comparing outcomes of the groups. There will be chart reviewing done comparing the groups.

Specific Aims

Our aim for both of these project is to compare MIST to other forms of delivering surfactant, and to show MIST does have improved outcomes when comparing to other forms of surfactant delivery.

Methods

For the QI project, we have developed a redcap for tracking and inputting data on patients. There is also a redcap filled out by providers each time a patient is given surfactant via MIST that provides some initial baseline data. We will then compare the two groups based on the proper statistical methods.

The clinical study is Multicenter, randomized, controlled trial. Inborn preterm infants 22 0/7-29 6/7 weeks gestation, will be randomized to prophylactic MIST surfactant in the delivery room compared to rescue surfactant when FiO2 is greater than or equal to 0.30 at less than 48 hours of age. Babies in both groups will be managed on CPAP. Primary outcome: Intubation in the first 7 days of age.

Secondary outcomes:

-Respiratory Incidence of composite outcome of death or physiological bronchopulmonary dysplasia (BPD). Durations of mechanical respiratory support, CPAP, high flow nasal cannula, (HFNC), oxygen therapy. Pneumothorax or pulmonary hemorrhage.

-Non respiratory neonatal morbidities intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotizing enterocolitis, and patent ductus arteriosus. Corrected age at discharge, length of hospital stay (a proxy for cost). Neonatal follow up data.

The above data will be collected until discharge. Babies born between 22 and 29 weeks are routinely followed by our developmental follow up clinic. The information from the 18 to 24 month developmental clinic visit will be recorded by the study

Required Software

Redcap access

Scholarship & Discovery Tracks: Clinical Research