Effect of Baby Positioning on Delayed Cord Clamping Outcomes
Prone Positioning During Delayed Cord Clamping: A Randomized Control Pilot Study to Identify Optimal Neonatal Positioning During Delayed Cord Clamping
This study is testing whether placing newborns on their stomachs instead of their backs during delayed cord clamping can help preterm babies breathe better and need less help with breathing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT05507424 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of positioning newborns on their stomachs versus their backs during delayed cord clamping after birth. Delayed cord clamping is a technique that allows for the transfer of oxygen and blood from the placenta to the newborn for 30-60 seconds post-delivery. The research aims to determine if the prone position can improve respiratory outcomes and reduce the need for intubation in preterm infants. By comparing the two positions, the study seeks to establish guidelines for optimal positioning during this critical time.
Who should consider this trial
Good fit: Ideal candidates include pregnant patients at risk for preterm delivery with a gestational age between 25 and 29 weeks.
Not a fit: Patients with triplet or higher order gestation or significant fetal anomalies that could affect respiratory status may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory outcomes and reduced need for oxygen support in preterm infants.
How similar studies have performed: While the specific positioning during delayed cord clamping is novel, previous studies have shown benefits of prone positioning in improving respiratory outcomes in newborns.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant patient admitted for diagnosis that could result in a preterm delivery * Anticipated gestational age of delivery could be between 25w+0d - 29w+6d * Fetus without major anomalies or known genetic condition that could impact respiratory status or need for intubation at birth * Singleton or twin gestation * Neonate eligible for delayed cord clamping based on institutional protocol * Patient is able to understand study procedures and is willing and able to consent Exclusion Criteria: * Triplet or higher order gestation * Maternal or fetal/neonatal contraindication to delayed cord clamping * Major fetal anomaly that would be expected to impact delivery room intubation rates such as: * Major congenital cardiac defect (not isolated atrial septal defect/ventricular septal defect) * Significant fetal arrhythmia at the time of delivery * Fetal tumor * Renal anhydramnios (not isolated urinary tract dilation with normal fluid) * Congenital Diaphragmatic Hernia * Heterotaxy * Moderate to severe ventriculomegaly or other major brain malformation (not mild isolated ventriculomegaly) * Airway obstruction * Underlying genetic disease that could impact respiratory function at delivery * Arthrogryposis (not apparently isolated clubbed foot) * Skeletal dysplasia * Pregnant patient is unable to understand study materials or is unwilling or unable to consent * Acute maternal obstetric emergency that precludes time or maternal focus for the consent process to take place
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- West Penn Hospital-Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Mara Rosner, MD — Johns Hopkins University
- Study coordinator: Katelyn Uribe, MD
- Email: kuribe1@jhmi.edu
- Phone: 717-781-3922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.