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Extended CPAP for Bronchopulmonary Dysplasia

N/A
Recruiting
Led By Anastasiya Latushko
Research Sponsored by Christiana Care Health Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Babies born at <30 weeks' gestation
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study Summary

This trial is testing whether keeping babies on CPAP or weaning them to HFNC will help decrease lung disease.

Who is the study for?
This trial is for premature babies born before 30 weeks' gestation and extubated to non-invasive ventilation by 32 weeks postmenstrual age. It's not suitable for infants needing less than 2L nasal cannula at birth, or those with congenital anomalies, skeletal, neuromuscular disorders, or genetic syndromes.Check my eligibility
What is being tested?
The study tests if keeping premature infants on CPAP support longer (until they're either 32 weeks corrected gestational age or weigh about 2 pounds and 12 ounces) helps reduce lung disease compared to weaning them earlier to high flow nasal cannula.See study design
What are the potential side effects?
Potential side effects may include discomfort from the CPAP mask, skin irritation where the mask fits, dry nose/mouth from airflow, possible stomach bloating and rarely lung complications due to pressure changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born before 30 weeks of pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Time to reach 2L NC or room air
Secondary outcome measures
Compliance to protocol and balancing measures

Trial Design

2Treatment groups
Active Control
Group I: Usual care groupActive Control1 Intervention
Infants randomized to this group will receive the present standard of care for weaning respiratory support. This means the attending provider will decide when each infant is ready to be changed from CPAP to nasal cannula and the nasal cannula will be weaned according to an existing unit protocol.
Group II: Protocol care groupActive Control1 Intervention
Infants randomized to this group will remain on CPAP until they are at least 32 weeks corrected gestational age or 1250g. At that point, if they meet a set of criteria, they will be transitioned to either 2L nasal cannula if they require supplemental oxygen or room air.

Find a Location

Who is running the clinical trial?

Christiana Care Health ServicesLead Sponsor
114 Previous Clinical Trials
105,591 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
78 Patients Enrolled for Bronchopulmonary Dysplasia
Anastasiya LatushkoPrincipal InvestigatorChristiana Care Health Services, Inc
Kelley Z Kovatis, MDPrincipal InvestigatorChristiana Care Health Services, Inc
3 Previous Clinical Trials
184 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
78 Patients Enrolled for Bronchopulmonary Dysplasia

Media Library

Protocolized weaning of respiratory support Clinical Trial Eligibility Overview. Trial Name: NCT05547139 — N/A
Bronchopulmonary Dysplasia Research Study Groups: Usual care group, Protocol care group
Bronchopulmonary Dysplasia Clinical Trial 2023: Protocolized weaning of respiratory support Highlights & Side Effects. Trial Name: NCT05547139 — N/A
Protocolized weaning of respiratory support 2023 Treatment Timeline for Medical Study. Trial Name: NCT05547139 — N/A

Frequently Asked Questions

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

Are individuals aged 45 and above eligible to participate in this trial?

"This clinical trial requires that potential participants are between 22 Weeks and 30 Weeks old. There are 255 trials for minors, and 184 studies exclusively looking at elderly patients."

Answered by AI

Am I eligible to join the experiment?

"To be considered for this clinical trial, the prospective participant must be diagnosed with bronchopulmonary dysplasia and within an age range of 22 Weeks to 30 Weeks. Altogether, a total of 60 individuals will be accepted into the study."

Answered by AI

Is there still the opportunity to join this investigation?

"Affirmative, the information found on clinicaltrials.gov verifies that this trial is recruiting participants as of now. It was first published on October 10th 2022 and has been amended most recently on October 17th 2022. The investigation requires 60 volunteers from one particular medical centre."

Answered by AI

How many participants are there in this clinical research study?

"Affirmative, the data posted on clinicaltrials.gov states that this research endeavour is actively looking for new participants. It was first announced on October 10th 2022 and most recently updated a week later on October 17th 2022. This trial requires 60 subjects to be enrolled at one particular medical centre."

Answered by AI
~15 spots leftby Oct 2024