Lung Ultrasound-Guided Respiratory Management in Infants (NeoLUS-RCT)

Tufts University

Status: Begins enrollment in 5 months

Conditions: Neonatal Respiratory Failure

Treatments: Procedure: Lung ultrasound-guided respiratory management

Study type: Interventional

Funder types: Other

Identifiers

NCT07386041

STUDY00006737

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Intervention - Lung ultrasound guided respiratory management

Experimental group

Description:

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

Treatment:

Procedure: Lung ultrasound-guided respiratory management

Control - Standard Clinical Care

No Intervention group

Description:

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.