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Structured CPAP Weaning for Neonatal Respiratory Failure (Flow&Grow Trial)

N/A
Recruiting
Led By Sandra Leibel, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4 months
Awards & highlights

Flow&Grow Trial Summary

This trial is studying if preemies kept on CPAP longer have fewer breathing problems. The hypothesis is that preemies kept on CPAP until a specific age will have lower rates of breathing problems.

Who is the study for?
This trial is for preterm infants born at less than 30 weeks' gestational age who are in the NICU and have not been intubated for over 4 weeks. Infants with long-term support needs due to conditions like pulmonary hypoplasia or genetic syndromes cannot participate.Check my eligibility
What is being tested?
The study tests a structured weaning protocol from CPAP, hypothesizing that maintaining it until at least 32-34 weeks corrected gestational age will reduce weaning failure compared to standard care.See study design
What are the potential side effects?
Since this trial involves a weaning protocol rather than medication, side effects may include typical risks associated with premature infant care such as difficulty breathing or increased need for respiratory support if the weaning fails.

Flow&Grow Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with CPAP/NIS weaning failure
Secondary outcome measures
Length of hospital stay
Number of participants experiencing pulmonary air leaks
Number of participants requiring supplemental oxygen
+13 more

Flow&Grow Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standardized NIS WeanExperimental Treatment1 Intervention
A standardized maintenance/weaning protocol will be implemented for the treatment group (standardized NIS wean). All infants in the treatment group will remain on NIS until either 32 or 34 weeks CGA, depending on their gestational age at birth. Infants born at 27 6/7 weeks or less will continue on NIS until at least 34 weeks if they are in the treatment group, whereas infants born between 28 0/7 and 29 6/7 weeks will stay on NIS until at least 32 weeks if they are in the treatment group. The weaning protocol in the treatment group will incorporate algorithms outlining stability criteria, failure criteria, and algorithms for registered nurses (RNs) and respiratory therapists (RTs), including steps to take in such situations. The control group will be weaned according to the unit's or medical team's practices.
Group II: ControlActive Control1 Intervention
Babies in the control group (non-standardized wean) will be weaned based on unit specific practices.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,122 Previous Clinical Trials
1,520,914 Total Patients Enrolled
Rady Children's Hospital, San DiegoOTHER
39 Previous Clinical Trials
13,403 Total Patients Enrolled
Sandra Leibel, MDPrincipal InvestigatorUniversity of California, San Diego
1 Previous Clinical Trials
25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to participate in this investigation?

"According to clinicaltrials.gov, the recruitment for this medical study is currently inactive; it was first posted on November 1st 2023 and last updated three days later. However, there are still 173 other studies that are actively recruiting patients right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
Sandra Leibel 2023. "Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06123143.
~87 spots leftby Nov 2028
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