Positioning During SBT in NICU Infants

NCT02835209 | Withdrawn

• 1 other identifier: DDD#603398
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Respiratory Distress Syndrome, Newborn; Ventilator-associated Lung Injury

Keywords

spontaneous breathing test; premature infant; work of breathing

Outcome Measures

Primary Outcomes (2)

• 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).

  Less than 1 hour

• 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)

  Less than 1 hour

Secondary Outcomes (2)

• WOB correlates of SBT pass rates

  Less than 1 hour

• WOB correlates of SBT fail rates

  Less than 1 hour

Study Arms (1)

Work of breathing during SBT

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

Other: Work of breathing during SBT

Interventions

Work of breathing during SBT OTHER

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

Work of breathing during SBT

Eligibility Criteria

• Age: 24 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Premature infants who are mechanically ventilated.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christiana Care Health Services: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Robert Locke, DO, MPH

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: July 18, 2016
• Study Start: November 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share