What side effects are associated with this type of intervention?

Delayed cord clamping (DCC) is generally considered safe and beneficial for newborns, as it allows for increased blood and oxygen transfer from the placenta. Common side effects are minimal but can include a slight increase in the risk of jaundice due to higher red blood cell volume, which may require phototherapy. There are no significant side effects related to the newborn's position during DCC, whether on the back or belly, as studied in the trial.

What prior FDA approvals exist?

Delayed Cord Clamping (DCC) is a procedural practice used in the delivery room where the newborn remains attached to the umbilical cord and placenta for 30-60 seconds after birth to maximize the transfer of oxygen and blood. There are no specific FDA-approved drugs for DCC as it is not a pharmacological treatment but a standard practice aimed at improving neonatal outcomes. The focus of current studies, such as the one on newborn positioning during DCC, is to optimize the procedure rather than introduce new drug treatments.

What other types of research exist?

One promising alternative to traditional newborn positioning during delayed cord clamping is the use of prone positioning (placing the newborn on their belly) instead of the conventional supine position (on their back). This approach is being studied to determine if it enhances the transfer of blood and oxygen from the placenta to the newborn. Additionally, the use of gravity-assisted techniques, where the newborn is held below the level of the placenta, is another novel method being explored to optimize blood flow during delayed cord clamping.

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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

No Placebo-Only Group

Summary

This trial is testing whether preterm babies should lie on their back or belly during delayed cord clamping right after birth. Delayed cord clamping means waiting a short time before cutting the umbilical cord to give the baby more blood and oxygen. The study aims to see if lying on the belly helps these babies breathe better and need less extra oxygen. Delayed umbilical cord clamping is associated with greater haemoglobin concentration and iron storage in the first few months of life and with less need of blood transfusion and lower incidence of neonatal hypotension compared to early umbilical 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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-60 seconds immediately after birth of the newborn

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of pre-term neonates that require endotracheal intubation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Delayed cord clamping (DCC) involves keeping the newborn attached to the umbilical cord for 30-60 seconds post-birth to maximize blood and oxygen transfer from the placenta. The primary mechanism of action for DCC is to allow for a greater volume of placental blood to enter the newborn's circulation, which can improve iron stores and hemoglobin levels, and reduce the risk of anemia. The position of the newborn during DCC (on the back versus on the belly) may influence the efficiency of this blood transfer. Ensuring optimal positioning can enhance the benefits of DCC by potentially improving the hemodynamic stability and oxygenation of the newborn.