PreTerm Neonate, Respiratory Distress Syndrome (RDS)
Conditions
Keywords
preterm infants, intubated, respiratory distress, extubation, work of breathing
Brief summary
The primary objective of this study is to compare work of breathing indices before and after extubation in intubated premature infants admitted to the Christiana Care Neonatal Intensive Care Unit. The secondary objective is to compare the ability of work of breathing indices to predict extubation failure to routine spontaneous breathing tests (SBTs) in intubated premature infants admitted to the ChristianaCare NICU.
Detailed description
For clinicians, the ability to accurately predict which infants will successfully extubate is essential. Doctors and nurses routinely use a combination of vital signs (heart rate, respiratory rate, oxygen saturations), physical examination and spontaneous breathing trials to determine a baby's readiness to have their breathing tube removed. A spontaneous breathing trial is routinely done in our NICU and involves reducing the support that the baby receives from the breathing machine while leaving the breathing tube in place. These methods do not always accurately predict which babies are ready to be extubated. This prospective observational pilot study will measure work of breathing (how hard or how easy a baby breathes) before, during and after the routine spontaneous breathing test is done. The study will also measure work of breathing before and after removal of the breathing tube, if a baby's medical team decides the baby is ready to have their tube removed. Work of breathing indices will be measured through respiratory inductive plethysmography (RIP). Soft elastic cloth bands will be placed around the baby's chest and abdomen. These bands measure how well the chest and abdomen work together when a baby breathes. We hypothesize that PneuRIP can predict extubation failure.
Interventions
OTHERObservation
Infants work of breathing will be observed through placement of soft elastic cloth bands on the infant's chest and abdomen. These bands measure how well the chest and abdomen work together when a baby breathes.
Sponsors
Christiana Care Health Services
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* premature infants (born at ≤32 weeks gestation) who are intubated. * medical team is evaluating the baby for extubation readiness
Exclusion criteria
* Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of RIP measurements will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work of breathing before and after extubation | 25 minutes | The primary objective of this study is to compare work of breathing indices before and after extubation in intubated premature infants admitted to the Christiana Care Neonatal Intensive Care Unit. We will observe work of breathing for 5-10 minutes before the infant is extubated and 5-10 minutes after the infant is extubated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability of work of breathing indices to predict extubation failure. | 25 minutes | The secondary objective is to compare the ability of work of breathing indices to predict extubation failure to routine spontaneous breathing tests (SBTs) in intubated premature infants admitted to the ChristianaCare NICU. We will record a baby's work of breathing measurements for 5-10 minutes before the routine spontaneous breathing test, up to 5 minutes during the spontaneous breathing test, and for 5-10 minutes after the spontaneous breathing test. |
Countries
United States
Contacts
CONTACTKelley Z. Kovatis, MD
CONTACTAmy B Mackley
PRINCIPAL_INVESTIGATORKelley Z Kovatis, MD
Christiana Care Health Services, Inc
Outcome results
None listed