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WithdrawnNCT02835209Updated Feb 5, 2018

Positioning During SBT in NICU Infants

An observational study in Respiratory Distress Syndrome, Newborn and Ventilator-associated Lung Injury, sponsored by Christiana Care Health Services. Withdrawn. Open to participants aged 24 Weeks to 34 Weeks. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by Christiana Care Health Services · Observational

Why this study was withdrawn
Change in clinical practice that logistically prevented this study from being engaged.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
24 Weeks to 34 Weeks
Sex
All
01

Study summary

Mechanical ventilation is a life-sustaining intervention in premature infants with respiratory difficulties. There is relative consensus when to intubate and provide positive pressure mechanical ventilation in the presence of respiratory failure. In contrast, discontinuation of mechanical ventilation during recovery remains largely subjective. A potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT). The efficacy of SBT or other tests used in older patient populations in improving clinical judgment is questionable in the neonatal population with its unique physiology, respiratory mechanics and drive factors. Christiana Care Health System NICU currently uses the SBT as a standard part of neonatal assessment for extubation from mechanical ventilation.

Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine, lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT. An SBT performed in one position may not predict infant respiratory status after extubation in another position. Understanding the impact of infant positioning and work of breathing indices independently or in combination with an SBT will aid clinicians in decision-making and potentially decrease neonatal morbidity (inaccuracy with timing and safety of extubation). This pilot study will begin to explore these clinically relevant factors.

Objectives: This pilot study will investigate the (1) role of infant position on SBT score and (2) the relationship of work of breathing indices in reference to the SBT score and infant position.

Read the detailed description

Mechanical ventilation is a life-sustaining intervention in premature infants with respiratory difficulties. There is relative consensus when to intubate and provide positive pressure mechanical ventilation in the presence of respiratory failure. In contrast, discontinuation of mechanical ventilation during recovery remains largely subjective. Typically 25% of infants weighing \<1500g who are extubated using these criteria require reintubation suggesting that the ability of clinicians to predict successful extubation is limited. A potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT). The efficacy of SBT or other tests used in older patient populations in improving clinical judgment is questionable in the neonatal population with its unique physiology, respiratory mechanics and drive factors.

Christiana Care Health System NICU currently uses the SBT as a standard part of neonatal assessment for extubation from mechanical ventilation.

The SBT used at CCHS is a non-invasive 5-minute test performed on an intubated infant. Respiratory rates (RR), expired tidal volume (Vte), heart rate, and oxygen saturation by pulse oximetry (SpO2) are recorded. An SBT is considered passed, when there is no apnea (defined as no respiratory effort for greater than 20 seconds), no bradycardia (defined as heart rate less than 100 for greater than 15 seconds), and the SpO2 has been maintained at greater than 85% or SBT VE greater than 60% than that of the mechanical VE.

Potentially confounding the SBT, and unstudied, is the effect of position (prone, supine, lateral). Similar to adults, infant position has a significant effect on the efficacy of spontaneous breathing. Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine, lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT. An SBT performed in one position may not predict infant respiratory status after extubation in another position. Understanding the impact of infant positioning and work of breathing indices independently or in combination with an SBT will aid clinicians in decision-making and potentially decrease neonatal morbidity (inaccuracy with timing and safety of extubation). This pilot study will begin to explore these clinically relevant factors.

Work of breathing (WOB) indices can be non-invasively measured utilizing respiratory inductive plethysmography (RIP). WOB indices measured by RIP have been utilized by this research team for clinical and research purposes, including at CCHS. RIP entails that an infant breathe calmly while wearing soft elastic cloth bands that comfortably encircle the rib cage and abdomen. Contained within the bands is a flexible sinusoidal wire that measures motion. Measurements are taken for a minimum of 10 breaths, but preferable throughout the duration of the 5 minutes SBT.

Objectives: This pilot study will investigate the (1) role of infant position on SBT score and (2) the relationship of work of breathing indices in reference to the SBT score and infant position.

02

Conditions studied

  • Respiratory Distress Syndrome, Newborn
  • Ventilator-associated Lung Injury

Keywords

  • spontaneous breathing test
  • premature infant
  • work of breathing
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Weeks to 34 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Premature infants who are mechanically ventilated.

Inclusion criteria

  • Infants born 24+0 to 34+6 weeks gestation
  • Intubated for a minimum of 24hrs
  • Qualify for an SBT as standard of care.

Exclusion criteria

Exclusion Criteria:

  • Previous history of abdominal or chest surgery
  • Congenital malformation of the chest or abdomen
  • Neuromuscular disorder
  • Current medications affecting neuro-muscular tone
  • Unable to be positioned either prone, supine or lateral as determined by the attending neonatologist.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Work of breathing during SBT

    Ventilated premature infants born 24 to 34+6 weeks gestational age.

    Other: Work of breathing during SBT

Interventions

  • OtherWork of breathing during SBT

    Pulmonary function tests and work of breathing indices will be collected during the spontaneous breathing test.

06

What researchers measure

Primary outcomes

  1. Impact of infant positioning on spontaneous breathing test (SBT) pass rates

    SBT will be performed with the infant in 3 different positions (supine, prone, side-lying).

    Time frame: Less than 1 hour

  2. Impact of infant positioning on spontaneous breathing test (SBT) fail rates

    SBT will be performed with the infant in 3 different positions (supine, prone, side-lying)

    Time frame: Less than 1 hour

Secondary outcomes

  1. WOB correlates of SBT pass rates

    Pulmonary function tests will be performed during the SBT in each position (supine, prone and side-lying).

    Time frame: Less than 1 hour

  2. WOB correlates of SBT fail rates

    Pulmonary function tests will be performed during the SBT in each position (supine, prone and side-lying).

    Time frame: Less than 1 hour

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — De-identified data would be shared in a data warehouse after a data use agreement was in place.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02835209
Lead sponsor
Christiana Care Health Services
Responsible party
Sponsor
First posted
Jul 18, 2016
Start date
Nov 2017 (estimated)
Primary completion
Jul 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Feb 5, 2018

Study contacts

Robert Locke, DO, MPH
principal investigator · Christiana Care Health Services

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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