Non Inferiority Trial Investigating Surfactants Administered Via MIST

Description

RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST. Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. Babies who require emergent intubation will not be enrolled in the interventions. Parental Consent will be obtained prior to randomization.

Conditions

Respiratory Distress Syndrome

Study Overview

Study Details

Study overview

RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST. Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. Babies who require emergent intubation will not be enrolled in the interventions. Parental Consent will be obtained prior to randomization.

Non Inferiority Trial Investigating Surfactants Administered Via MIST

Non Inferiority Trial Investigating Surfactants Administered Via MIST

Condition
Respiratory Distress Syndrome
Intervention / Treatment

-

Contacts and Locations

Evanston

Northshore University Healthsystem, Evanston, Illinois, United States, 60201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30
  • * Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.
  • * Infants who require emergent intubation will not be enrolled in the interventions.

Ages Eligible for Study

to 48 Hours

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NorthShore University HealthSystem,

Study Record Dates

2027-12-01