Health TrialsbyHealthPanel

Lung Ultrasound-Guided Respiratory Management in Infants

ConditionNeonatal Respiratory Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-1
SponsorTufts Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Infants admitted to the Tufts Medical Center NICU

Requiring invasive or non-invasive respiratory support

Requiring surfactant therapy

Parental or guardian informed consent obtained

Disqualifiers

Major congenital anomalies

Known chromosomal abnormalities

Congenital diaphragmatic hernia

Decision for comfort care

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lung ultrasound-guided respiratory management

    Procedure/Surgery

    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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Intervention - Lung ultrasound guided respiratory managementExperimental treatment 1 intervention
Group B: Control - Standard Clinical CareNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: