An observational study in Respiratory Distress Syndrome (RDS) and PreTerm Neonate, sponsored by Christiana Care Health Services. Recruiting at 1 site in United States. Open to participants aged 0 Days to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Christiana Care Health Services · Observational
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.
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
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The study population includes premature infants, admitted to the NICU at Christiana care and who are intubated.
Exclusion Criteria:
There is only one cohort for this study and it includes preterm infants who are intubated.
Other: Observation
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.
Work of breathing before and after extubation
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.
Time frame: 25 minutes
Ability of work of breathing indices to predict extubation failure.
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.
Time frame: 25 minutes
Plan to share: No
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