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NCT Number: NCT07386041

Lung Ultrasound-Guided Respiratory Management in Infants

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.

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Key information

Age range

0 year–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Length of NICU stay (days)

    Time frame: From date of NICU admission to date of hospital discharge up to one year

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. Weaning failure

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

  5. Need for reintubation

    Time frame: From date of extubation, to date of reintubation, up to 72 hours.

  6. 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.

  7. Mortality prior to discharge

    Time frame: From date of birth until the date of death from any cause, assessed up to one year.

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

Lung Ultrasound-Guided Respiratory Management in Infants: A Single-Center Randomized Controlled Trial

Acronym: NeoLUS-RCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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