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NCT Number: NCT07542301

Breathing Patterns in Infants 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. 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.

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Key information

Conditions

Respiratory Distress Syndrome (RDS) Dyspnea Lung Diseases Pathological Conditions, Signs and Symptoms PreTerm Neonate Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

0 day–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

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.

Primary outcomes

  1. Work of breathing before and after extubation

    Time frame: 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 outcomes

  1. Ability of work of breathing indices to predict extubation failure.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy B Mackley

CONTACT

[email protected]

MSN, RNC, CCRC

Kelley Z. Kovatis, MD

CONTACT

[email protected]

302-301-2410

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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