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CPAP for Premature Birth (PLANT Trial)

N/A

Recruiting

Led By Birju A Shah, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Inborn newborns delivered by Cesarean section

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 30 minutes after birth

Awards & highlights

PLANT Trial Summary

This trialevaluates if CPAP with/without oxygen helps late preterm infants born by C-section breathe better & need fewer NICU admissions.

Who is the study for?

This trial is for late preterm infants born by C-section, specifically those with a gestational age between 34 and less than 37 weeks. Infants must be inborn (delivered at the hospital where the trial is conducted). Those with major congenital anomalies or conditions that severely limit life expectancy, such as pulmonary hypoplasia, cannot participate.Check my eligibility

What is being tested?

The study tests if giving early prophylactic Continuous Positive Airway Pressure (CPAP), with or without extra oxygen, to spontaneously breathing late preterm infants can reduce the need for additional respiratory support and NICU admissions compared to not using early CPAP.See study design

What are the potential side effects?

While CPAP is generally safe, potential side effects may include minor skin irritation from the mask, nasal congestion or nosebleeds, bloating of the stomach, discomfort in breathing due to pressure changes.

PLANT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My newborn was delivered via Cesarean section.

PLANT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 30 minutes after birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first 30 minutes after birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 30 minutes after birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse outcomes

Effectiveness

Secondary outcome measures

Proportion of newborns with protocol adherence and compliance

PLANT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prophylactic Delivery Room Continuous Positive Airway PressureExperimental Treatment1 Intervention

If the infant is spontaneously breathing and allocated to the experimental arm, s/he will receive 20 min of 5 cm H2O of prophylactic continuous airway pressure using either a face mask or the appropriate size of nasal prong.

Group II: No Prophylactic Delivery Room Continuous Positive Airway PressureActive Control1 Intervention

Alternatively, spontaneously breathing infants assigned to control group will receive the standard of care with no prophylactic delivery room continuous positive airway pressure (CPAP). In both groups, CPAP can be used to help babies with persistent labored breathing or cyanosis after the initial steps as per the participating institution's neonatal resuscitation protocol. At any time, if the patient does not present spontaneous breathing, an escalation on the resuscitation measures will be performed and the study intervention will be terminated.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityOTHER

980 Previous Clinical Trials

981,640 Total Patients Enrolled

10 Trials studying Premature Birth

7,572 Patients Enrolled for Premature Birth

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,801 Total Patients Enrolled

9 Trials studying Premature Birth

833 Patients Enrolled for Premature Birth

Pontificia Universidad Catolica de ChileOTHER

206 Previous Clinical Trials

161,966 Total Patients Enrolled

3 Trials studying Premature Birth

2,475 Patients Enrolled for Premature Birth

Media Library

Continuous Positive Airway Pressure Clinical Trial Eligibility Overview. Trial Name: NCT05204719 — N/A

Premature Birth Research Study Groups: Prophylactic Delivery Room Continuous Positive Airway Pressure, No Prophylactic Delivery Room Continuous Positive Airway Pressure

Premature Birth Clinical Trial 2023: Continuous Positive Airway Pressure Highlights & Side Effects. Trial Name: NCT05204719 — N/A

Continuous Positive Airway Pressure 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204719 — N/A

Frequently Asked Questions

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

Are elderly individuals being included in this experiment?

"Patients aged between 1 Minute and 5 Minutes years old are being recruited for this study."

Answered by AI

In how many healthcare facilities is this research endeavor being conducted?

"At this point in time, 4 clinical trial sites are accepting patient enrolment. These include New york, Oklahoma City, and Edmonton - to name a few - with the aim of making it easier for patients to join by minimising their travel needs."

Answered by AI

Who is eligible to enroll in this research evaluation?

"This research study is looking to enroll 122 infants aged between one and five minutes old who were born prematurely. To meet the inclusion criteria, these newborns must have been delivered via cesarean section and gestational age must be within 34-37 weeks."

Answered by AI

Are there vacancies for this experiment that are still open?

"Per the clinicaltrials.gov website, this investigation is no longer enrolling participants. It was initially listed on January 1st 2023 and last modified on the 9th of that month. Nevertheless, there are 249 other trials currently in need of volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prophylactic DR-CPAP on Late Preterm Infants Born by C-section: an RCT

2023. "Prophylactic DR-CPAP on Late Preterm Infants Born by C-section: an RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05204719.