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Prone vs Supine Positioning for Delayed Cord Clamping

N/A
Recruiting
Led By Mara Rosner, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-60 seconds immediately after birth of the newborn
Awards & highlights

Study Summary

This trial is testing whether it's better for newborns to lay on their back or stomach during delayed cord clamping.

Who is the study for?
This trial is for newborns eligible for delayed cord clamping, with a gestational age of 25-29 weeks. It's open to single or twin pregnancies where the baby has no major anomalies or genetic conditions affecting breathing or need for intubation at birth. Mothers must understand and consent to the study.Check my eligibility
What is being tested?
The study is testing whether it's better for newborns to be on their back (supine) or belly (prone) during the first 30-60 seconds after birth when delayed cord clamping is performed, which allows maximum blood and oxygen transfer from placenta.See study design
What are the potential side effects?
Since this trial involves positioning of newborns without any medication administration, there are no direct side effects related to drugs; however, monitoring will be in place for any potential complications arising from the positioning.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-60 seconds immediately after birth of the newborn
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-60 seconds immediately after birth of the newborn 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 pre-term neonates that require endotracheal intubation

Trial Design

2Treatment groups
Active Control
Group I: Prone Positioning During Delayed Cord ClampingActive Control2 Interventions
Newborns delivered between 25w+0d and 29w+6d gestation who have been randomized in 1:1 fashion to prone positioning during routine delayed cord clamping.
Group II: Supine Positioning During Delayed Cord ClampingActive Control2 Interventions
Newborns delivered between 25w+0d and 29w+6d gestation who have been randomized in 1:1 fashion to supine positioning during routine delayed cord clamping.

Find a Location

Who is running the clinical trial?

West Penn Allegheny Health SystemOTHER
35 Previous Clinical Trials
5,749 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,822,905 Total Patients Enrolled
Mara Rosner, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Prone Positioning Clinical Trial Eligibility Overview. Trial Name: NCT05507424 — N/A
Delayed Cord Clamping Research Study Groups: Prone Positioning During Delayed Cord Clamping, Supine Positioning During Delayed Cord Clamping
Delayed Cord Clamping Clinical Trial 2023: Prone Positioning Highlights & Side Effects. Trial Name: NCT05507424 — N/A
Prone Positioning 2023 Treatment Timeline for Medical Study. Trial Name: NCT05507424 — N/A

Frequently Asked Questions

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

What is the aggregate number of participants engaging in this clinical experiment?

"Verified. The clinical trial posted on August 9th 2022 is actively searching for participants, as per the data presented on clinicaltrials.gov. This study requires 260 individuals to sign up from two different sites and was last updated October 5th 2022."

Answered by AI

Are there any qualifications to partake in this clinical trial?

"This particular clinical trial requires 260 participants aged 18-55 who have experienced delayed cord clamping. In addition, prospective enrollees must be pregnant and admitted for a diagnosis that could lead to preterm delivery; the neonate should not suffer from major anomalies or genetic conditions impacting respiration; singleton/twin gestation is sufficient; eligibility for delayed cord clamping based on institutional protocol must also be met; finally, all candidates need to demonstrate comprehension of study procedures along with an ability and willingness to consent. The gestational age range eligible for enrollment extends from 25w+0d - 29w+6d."

Answered by AI

Are there any available slots for participants in this research trial?

"Affirmative. According to clinicaltrials.gov, this scientific research is presently recruiting participants and was first made available on August 9th 2022 (last updated October 5th). A total of 260 volunteers are being sought from two sites."

Answered by AI

Are candidates aged over 30 years being considered for this research?

"Only those over 18 and younger than 55 can be considered for participation in this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prone Positioning During Delayed Cord Clamping
2022. "Prone Positioning During Delayed Cord Clamping". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05507424.
~173 spots leftby Aug 2028
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