Lung Ultrasound-Guided Respiratory Management in Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lung ultrasound-guided respiratory management.
- Who it may be relevant to
- Registry conditions: Neonatal Respiratory Failure. Basic parameters: 0 years — 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Lung Ultrasound-Guided Respiratory Management in Infants: A Single-Center Randomized Controlled Trial
Overview
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in infants requiring respiratory support. The primary outcome measure is length of NICU stay.
Detailed description
Infants, especially premature infants, frequently require respiratory support in the neonatal intensive care unit (NICU). Lung ultrasound is a bedside, radiation-free tool that can assess lung aeration and guide respiratory management, but its effect on clinical outcomes has not been evaluated in a U.S. randomized trial.
This single-center randomized controlled study will compare lung ultrasound-guided respiratory management with standard clinical care in premature infants requiring respiratory support. In the intervention group, lung ultrasound scores will guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air using predefined thresholds. The control group will use standard care to guide surfactant administration, weaning non-invasive respiratory support, and weaning from non-invasive respiratory support to room air.
The primary outcome is length of NICU stay. Secondary outcomes include duration of respiratory support, time on non-invasive respiratory support, time to successful weaning to room air, need for re-intubation, surfactant dosing, and mortality prior to discharge. This study aims to determine whether lung ultrasound-guided management can improve respiratory care and reducive hospital length of stay in infants requiring respiratory suppport.
Interventions
- Procedure Lung ultrasound-guided respiratory management
Scheduled lung ultrasounds are performed to guide decisions about surfactant administration, non-invasive respiratory support weaning, and transition to room air using predefined lung ultrasound score thresholds.
Primary outcome measures
- Length of NICU stay (days) [Time frame: From date of NICU admission to date of hospital discharge up to one year]
Secondary outcome measures (7)
- Duration of any respiratory support [Time frame: From date of initiation of respiratory support to date of discontinuation of respiratory support, up to one year]
- Duration of non-invasive respiratory support [Time frame: From date of initiation of non-invasive respiratory support to date of discontinuation of non-invasive respiratory support up to one year.]
- Time to successful weaning to room air [Time frame: From date of initiation of respiratory support to date of sustained room air without support for at least 48h, up to one year.]
- Weaning failure [Time frame: From date of weaning respiratory support, to date of re-escalation of respiratory support if needed, up to 72 hours]
- Need for reintubation [Time frame: From date of extubation, to date of reintubation, up to 72 hours.]
- Number of surfactant doses administered [Time frame: Number of surfactant doses quantified over the course through study completion, up to an average of 1 year.]
- Mortality prior to discharge [Time frame: From date of birth until the date of death from any cause, assessed up to one year.]
Eligibility criteria
Inclusion criteria
- Infants admitted to the Tufts Medical Center NICU
- Requiring invasive or non-invasive respiratory support
- Requiring surfactant therapy
- Parental or guardian informed consent obtained
Exclusion criteria
- Major congenital anomalies
- Known chromosomal abnormalities
- Congenital diaphragmatic hernia
- Decision for comfort care
- Surfactant administered prior to transfer from outside hospital (only excluded for surfactant decisions)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3. PMID 26237465
- Gathright M, Chacko A, Paulson M, O'Connor B, Mansky R, Lasarev M, Cowan E, Hulse W, Monroe E, Alfaro E, Baker M, Bauer AS, Diego E. An Evaluation of Vital Signs in Intubated Neonates Undergoing Lung Point-of-Care Ultrasound in the Neonatal Intensive Care Unit. J Clin Ultrasound. 2026 Jun;54(5):1072-1078. doi: 10.1002/jcu.70161. Epub 2025 Dec 22. PMID 41427513
Identifiers
NCT: NCT07386041 · STUDY00006737