Lung Ultrasound-Guided Respiratory Management in Infants

NCT07386041 | Not Yet Recruiting

• 1 other identifier: STUDY00006737
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neonatal Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Length of NICU stay (days)

  From date of NICU admission to date of hospital discharge up to one year

Secondary Outcomes (7)

• Duration of any respiratory support

  From date of initiation of respiratory support to date of discontinuation of respiratory support, up to one year

• Duration of non-invasive respiratory support

  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

  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

  From date of weaning respiratory support, to date of re-escalation of respiratory support if needed, up to 72 hours

• Need for reintubation

  From date of extubation, to date of reintubation, up to 72 hours.

Study Arms (2)

Intervention - Lung ultrasound guided respiratory management

EXPERIMENTAL

Participants randomized to this group will under lung ultrasound assessments at predefined clinical time points. Lung ultrasound scores will guide: * Surfactant administration in the early neonatal period * Weaning from non-invasive respiratory suppport * Transition to room air Decisions will follow predefined lung ultrasound score thresholds using a validating scoring system. Ultrasounds to be performed by trained neonatal providers using standardized techniques. Attending neonatologists may override protocol recommendations if clinically necessary, with documentation

Procedure: Lung ultrasound-guided respiratory management

Control - Standard Clinical Care

NO INTERVENTION

Participants randomized to this group will receive respiratory management based on standard NICU clinical criteria including oxygen requirement, work of breathing, blood gas measurements, and radiographic findings. Lung ultrasound may be performed if clinically indicated, but will not be used for protocolized decision making.

Interventions

Lung ultrasound-guided respiratory management PROCEDURE

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.

Intervention - Lung ultrasound guided respiratory management

Eligibility Criteria

• Age: 0 Years - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants admitted to the Tufts Medical Center NICU
• Requiring invasive or non-invasive respiratory support
• Requiring surfactant therapy
• Parental or guardian informed consent obtained

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tufts Medical Center: lead

Related Publications (2)

• 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 BACKGROUND

• 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. 2025 Dec 22. doi: 10.1002/jcu.70161. Online ahead of print.

  PMID: 41427513 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical care teams cannot be blinded due to the nature of the intervention. Outcome assessors and statisticians analyzing study outcomes will remain blinded to group assignment. Therefore it will be single masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio to either the lung ultrasound-guided respiratory management group or the standard care group. Both groups are followed concurrently to compare outcomes.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 4, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share